- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433340
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study
June 23, 2017 updated by: AbbVie
Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.
Study Overview
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963.
If female, subject must meet one of the following criteria:
- Postmenopausal (defined as no menses for at least 1 year).
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
- Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
- Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
Exclusion Criteria: - Pregnant or breastfeeding female.
- Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
- Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
- Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABT-122 120 mg EOW
All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American College of Rheumatology (ACR) 20 Response Rate at Week 2
Time Frame: Week 2 of Study M12-963
|
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 2 of Study M12-963
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ACR20 Response Rate at Week 4
Time Frame: Week 4 of Study M12-963
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 4 of Study M12-963
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ACR20 Response Rate at Week 6
Time Frame: Week 6 of Study M12-963
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 6 of Study M12-963
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ACR20 Response Rate at Week 8
Time Frame: Week 8 of Study M12-963
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 8 of Study M12-963
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ACR20 Response Rate at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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ACR20 Response Rate at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 16 (Week 4 of Study M12-965)
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ACR20 Response Rate at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 20 (Week 8 of Study M12-965)
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ACR20 Response Rate at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 24 (Week 12 of Study M12-965)
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ACR20 Response Rate at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 28 (Week 16 of Study M12-965)
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ACR20 Response Rate at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 32 (Week 20 of Study M12-965)
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ACR20 Response Rate at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
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Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 36 (Week 24 of Study M12-965)
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ACR50 Response Rate at Week 2
Time Frame: Week 2 of Study M12-963
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 2 of Study M12-963
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ACR50 Response Rate at Week 4
Time Frame: Week 4 of Study M12-963
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 4 of Study M12-963
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ACR50 Response Rate at Week 6
Time Frame: Week 6 of Study M12-963
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 6 of Study M12-963
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ACR50 Response Rate at Week 8
Time Frame: Week 8 of Study M12-963
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 8 of Study M12-963
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ACR50 Response Rate at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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ACR50 Response Rate at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 16 (Week 4 of Study M12-965)
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ACR50 Response Rate at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 20 (Week 8 of Study M12-965)
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ACR50 Response Rate at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 24 (Week 12 of Study M12-965)
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ACR50 Response Rate at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 28 (Week 16 of Study M12-965)
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ACR50 Response Rate at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 32 (Week 20 of Study M12-965)
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ACR50 Response Rate at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
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Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 36 (Week 24 of Study M12-965)
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ACR70 Response Rate at Week 2
Time Frame: Week 2 of Study M12-963
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 2 of Study M12-963
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ACR70 Response Rate at Week 4
Time Frame: Week 4 of Study M12-963
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 4 of Study M12-963
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ACR70 Response Rate at Week 6
Time Frame: Week 6 of Study M12-963
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 6 of Study M12-963
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ACR70 Response Rate at Week 8
Time Frame: Week 8 of Study M12-963
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 8 of Study M12-963
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ACR70 Response Rate at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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ACR70 Response Rate at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 16 (Week 4 of Study M12-965)
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ACR70 Response Rate at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 20 (Week 8 of Study M12-965)
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ACR70 Response Rate at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 24 (Week 12 of Study M12-965)
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ACR70 Response Rate at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 28 (Week 16 of Study M12-965)
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ACR70 Response Rate at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 32 (Week 20 of Study M12-965)
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ACR70 Response Rate at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
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Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 36 (Week 24 of Study M12-965)
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Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths
Time Frame: from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
For more details on adverse events please see the Adverse Event section.
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from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline In Tender Joint Count (TJC68) at Week 2
Time Frame: Week 2 of Study M12-963
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At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 2 of Study M12-963
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Change From Baseline in TJC68 at Week 4
Time Frame: Week 4 of Study M12-963
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At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 4 of Study M12-963
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Change From Baseline in TJC68 at Week 6
Time Frame: Week 6 of Study M12-963
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At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 6 of Study M12-963
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Change From Baseline in TJC68 at Week 8
Time Frame: Week 8 of Study M12-963
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 8 of Study M12-963
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Change From Baseline in TJC68 at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Change From Baseline in TJC68 at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 16 (Week 4 of Study M12-965)
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Change From Baseline in TJC68 at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 20 (Week 8 of Study M12-965)
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Change From Baseline in TJC68 at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 24 (Week 12 of Study M12-965)
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Change From Baseline in TJC68 at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 28 (Week 16 of Study M12-965)
|
Change From Baseline in TJC68 at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 32 (Week 20 of Study M12-965)
|
Change From Baseline in TJC68 at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 36 (Week 24 of Study M12-965)
|
Change From Baseline in Swollen Joint Count (SJC66) at Week 2
Time Frame: Week 2 of Study M12-963
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 2 of Study M12-963
|
Change From Baseline in SJC66 at Week 4
Time Frame: Week 4 of Study M12-963
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 4 of Study M12-963
|
Change From Baseline in SJC66 at Week 6
Time Frame: Week 6 of Study M12-963
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 6 of Study M12-963
|
Change From Baseline in SJC66 at Week 8
Time Frame: Week 8 of Study M12-963
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 8 of Study M12-963
|
Change From Baseline in SJC66 at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Change From Baseline in SJC66 at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 16 (Week 4 of Study M12-965)
|
Change From Baseline in SJC66 at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 20 (Week 8 of Study M12-965)
|
Change From Baseline in SJC66 at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 24 (Week 12 of Study M12-965)
|
Change From Baseline in SJC66 at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 28 (Week 16 of Study M12-965)
|
Change From Baseline in SJC66 at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 32 (Week 20 of Study M12-965)
|
Change From Baseline in SJC66 at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons.
The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced.
The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 36 (Week 24 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 2
Time Frame: Week 2 of Study M12-963
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS).
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 2 of Study M12-963
|
Change From Baseline in Patient's Assessment of Pain at Week 4
Time Frame: Week 4 of Study M12-963
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 4 of Study M12-963
|
Change From Baseline in Patient's Assessment of Pain at Week 6
Time Frame: Week 6 of Study M12-963
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 6 of Study M12-963
|
Change From Baseline in Patient's Assessment of Pain at Week 8
Time Frame: Week 8 of Study M12-963
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 8 of Study M12-963
|
Change From Baseline in Patient's Assessment of Pain at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 16 (Week 4 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 20 (Week 8 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 24 (Week 12 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 28 (Week 16 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 32 (Week 20 of Study M12-965)
|
Change From Baseline in Patient's Assessment of Pain at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS.
The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 36 (Week 24 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2
Time Frame: Week 2 of Study M12-963
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 2 of Study M12-963
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4
Time Frame: Week 4 of Study M12-963
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 4 of Study M12-963
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6
Time Frame: Week 6 of Study M12-963
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 6 of Study M12-963
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8
Time Frame: Week 8 of Study M12-963
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 8 of Study M12-963
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 16 (Week 4 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 20 (Week 8 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 24 (Week 12 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 28 (Week 16 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 32 (Week 20 of Study M12-965)
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 36 (Week 24 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2
Time Frame: Week 2 of Study M12-963
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 2 of Study M12-963
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4
Time Frame: Week 4 of Study M12-963
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 4 of Study M12-963
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6
Time Frame: Week 6 of Study M12-963
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 6 of Study M12-963
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8
Time Frame: Week 8 of Study M12-963
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 8 of Study M12-963
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 16 (Week 4 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 20 (Week 8 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 24 (Week 12 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 28 (Week 16 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 32 (Week 20 of Study M12-965)
|
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS.
The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 36 (Week 24 of Study M12-965)
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2
Time Frame: Week 2 of Study M12-963
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 2 of Study M12-963
|
Change From Baseline in HAQ-DI at Week 4
Time Frame: Week 4 of Study M12-963
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 4 of Study M12-963
|
Change From Baseline in HAQ-DI at Week 6
Time Frame: Week 6 of Study M12-963
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 6 of Study M12-963
|
Change From Baseline in HAQ-DI at Week 8
Time Frame: Week 8 of Study M12-963
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 8 of Study M12-963
|
Change From Baseline in HAQ-DI at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Change From Baseline in HAQ-DI at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 16 (Week 4 of Study M12-965)
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Change From Baseline in HAQ-DI at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
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HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 20 (Week 8 of Study M12-965)
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Change From Baseline in HAQ-DI at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 24 (Week 12 of Study M12-965)
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Change From Baseline in HAQ-DI at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
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HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 28 (Week 16 of Study M12-965)
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Change From Baseline in HAQ-DI at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
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HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 32 (Week 20 of Study M12-965)
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Change From Baseline in HAQ-DI at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
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HAQ-DI is a self-reported participant outcome measurement.
It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
The higher the score, the more likely to associate with morbidity and mortality for the participant.
The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 36 (Week 24 of Study M12-965)
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2
Time Frame: Week 2 of Study M12-963
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 2 of Study M12-963
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Change From Baseline in hsCRP at Week 4
Time Frame: Week 4 of Study M12-963
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 4 of Study M12-963
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Change From Baseline in hsCRP at Week 6
Time Frame: Week 6 of Study M12-963
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 6 of Study M12-963
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Change From Baseline in hsCRP at Week 8
Time Frame: Week 8 of Study M12-963
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 8 of Study M12-963
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Change From Baseline in hsCRP at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Change From Baseline in hsCRP at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 16 (Week 4 of Study M12-965)
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Change From Baseline in hsCRP at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 20 (Week 8 of Study M12-965)
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Change From Baseline in hsCRP at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 24 (Week 12 of Study M12-965)
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Change From Baseline in hsCRP at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 28 (Week 16 of Study M12-965)
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Change From Baseline in hsCRP at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 32 (Week 20 of Study M12-965)
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Change From Baseline in hsCRP at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
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For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 36 (Week 24 of Study M12-965)
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Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2
Time Frame: Week 2 of Study M12-963
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 2 of Study M12-963
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Change From Baseline in DAS28 (hsCRP) at Week 4
Time Frame: Week 4 of Study M12-963
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 4 of Study M12-963
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Change From Baseline in DAS28 (hsCRP) at Week 6
Time Frame: Week 6 of Study M12-963
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 6 of Study M12-963
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Change From Baseline in DAS28 (hsCRP) at Week 8
Time Frame: Week 8 of Study M12-963
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 8 of Study M12-963
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Change From Baseline in DAS28 (hsCRP) at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 16 (Week 4 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 20 (Week 8 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 24 (Week 12 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 28 (Week 16 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 32 (Week 20 of Study M12-965)
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Change From Baseline in DAS28 (hsCRP) at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 to 10, with higher scores indicating more disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 36 (Week 24 of Study M12-965)
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2
Time Frame: Week 2 of Study M12-963
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CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 2 of Study M12-963
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Change From Baseline in CDAI at Week 4
Time Frame: Week 4 of Study M12-963
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 4 of Study M12-963
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Change From Baseline in CDAI at Week 6
Time Frame: Week 6 of Study M12-963
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 6 of Study M12-963
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Change From Baseline in CDAI at Week 8
Time Frame: Week 8 of Study M12-963
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 8 of Study M12-963
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Change From Baseline in CDAI at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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Change From Baseline in CDAI at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 16 (Week 4 of Study M12-965)
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Change From Baseline in CDAI at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 20 (Week 8 of Study M12-965)
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Change From Baseline in CDAI at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 24 (Week 12 of Study M12-965)
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Change From Baseline in CDAI at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
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CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 28 (Week 16 of Study M12-965)
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Change From Baseline in CDAI at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 32 (Week 20 of Study M12-965)
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Change From Baseline in CDAI at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.
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Week 36 (Week 24 of Study M12-965)
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Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2
Time Frame: Week 2 of Study M12-963
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Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 2 of Study M12-963
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4
Time Frame: Week 4 of Study M12-963
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 4 of Study M12-963
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6
Time Frame: Week 6 of Study M12-963
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 6 of Study M12-963
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8
Time Frame: Week 8 of Study M12-963
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 8 of Study M12-963
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 16 (Week 4 of Study M12-965)
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
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Week 20 (Week 8 of Study M12-965)
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LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 24 (Week 12 of Study M12-965)
|
LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 28 (Week 16 of Study M12-965)
|
LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 32 (Week 20 of Study M12-965)
|
LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Percentage of participants achieving LDA or CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 36 (Week 24 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 2
Time Frame: Week 2 of Study M12-963
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 2 of Study M12-963
|
CR Response Rate Per DAS28 (hsCRP) at Week 4
Time Frame: Week 4 of Study M12-963
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 4 of Study M12-963
|
CR Response Rate Per DAS28 (hsCRP) at Week 6
Time Frame: Week 6 of Study M12-963
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 6 of Study M12-963
|
CR Response Rate Per DAS28 (hsCRP) at Week 8
Time Frame: Week 8 of Study M12-963
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 8 of Study M12-963
|
CR Response Rate Per DAS28 (hsCRP) at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 16 (Week 4 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 20 (Week 8 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 24 (Week 12 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 28 (Week 16 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 32 (Week 20 of Study M12-965)
|
CR Response Rate Per DAS28 (hsCRP) at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Percentage of participants achieving CR on the DAS28 (hsCRP).
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score.
Scores range from 0 (no disease activity) to 10 (highest degree of disease activity).
LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 36 (Week 24 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 2
Time Frame: Week 2 of Study M12-963
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 2 of Study M12-963
|
LDA or CR Response Rate Per CDAI at Week 4
Time Frame: Week 4 of Study M12-963
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 4 of Study M12-963
|
LDA or CR Response Rate Per CDAI at Week 6
Time Frame: Week 6 of Study M12-963
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 6 of Study M12-963
|
LDA or CR Response Rate Per CDAI at Week 8
Time Frame: Week 8 of Study M12-963
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 8 of Study M12-963
|
LDA or CR Response Rate Per CDAI at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 16 (Week 4 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 20 (Week 8 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 24 (Week 12 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 28 (Week 16 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 32 (Week 20 of Study M12-965)
|
LDA or CR Response Rate Per CDAI at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Percentage of participants achieving LDA or CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 36 (Week 24 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 2
Time Frame: Week 2 of Study M12-963
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 2 of Study M12-963
|
CR Response Rate Per CDAI Criteria at Week 4
Time Frame: Week 4 of Study M12-963
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 4 of Study M12-963
|
CR Response Rate Per CDAI Criteria at Week 6
Time Frame: Week 6 of Study M12-963
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 6 of Study M12-963
|
CR Response Rate Per CDAI Criteria at Week 8
Time Frame: Week 8 of Study M12-963
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 8 of Study M12-963
|
CR Response Rate Per CDAI Criteria at Week 12
Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 16
Time Frame: Week 16 (Week 4 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 16 (Week 4 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 20
Time Frame: Week 20 (Week 8 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 20 (Week 8 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 24
Time Frame: Week 24 (Week 12 of Study M12-965)
|
Percentage of participants achieving CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 24 (Week 12 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 28
Time Frame: Week 28 (Week 16 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 28 (Week 16 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 32
Time Frame: Week 32 (Week 20 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 32 (Week 20 of Study M12-965)
|
CR Response Rate Per CDAI Criteria at Week 36
Time Frame: Week 36 (Week 24 of Study M12-965)
|
Percentage of participants achieving CR per CDAI criteria.
The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm.
The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8.
Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
|
Week 36 (Week 24 of Study M12-965)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paul Peloso, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.
- Genovese MC, Weinblatt ME, Mease PJ, Aelion JA, Peloso PM, Chen K, Li Y, Liu J, Othman AA, Khatri A, Mansikka HT, Leszczynski P. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis. Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 10.1093/rheumatology/key173.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 2, 2015
First Submitted That Met QC Criteria
April 29, 2015
First Posted (Estimate)
May 5, 2015
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
June 23, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M12-965
- 2014-001471-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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