- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986373
A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)
May 3, 2019 updated by: AbbVie
A Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (1311.5)
This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).
Study Overview
Detailed Description
Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; the lead-in study) were eligible to enroll in M16-244 (this study).
Participants were allowed to either finish the Week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.
Study Type
Interventional
Enrollment (Actual)
145
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants who have completed all doses of study drug and Week 24 visit of the lead-in study.
- Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given.
- Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
- Participants 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 study specific procedures.
- Participant is judged to be in good health as determined by the Investigator.
Exclusion Criteria:
- Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given.
- Premature discontinuation of the study drug in the lead-in study for any reason.
- Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study.
- Time elapsed is > 8 weeks since the Week 24 visit in the lead-in study.
- Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.
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: Risankizumab
Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.
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Risankizumab administered by subcutaneous injection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
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An adverse event (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.
A serious adverse event (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) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose.
Abbreviations: NMSC=non-melanoma skin cancer
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From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study
Time Frame: Baseline (Lead-in Study), Week 24 (Lead-in Study)
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The mTSS is a measure of change in joint health.
X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48.
Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]).
An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 24 (Lead-in Study)
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mTSS: Change From Baseline (in the Lead-in Study) to Week 24
Time Frame: Baseline (Lead-in Study), Week 24
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The mTSS is a measure of change in joint health.
X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48.
Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]).
An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 24
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mTSS: Change From Baseline (in the Lead-in Study) to Week 48
Time Frame: Baseline (Lead-in Study), Week 48
|
The mTSS is a measure of change in joint health.
X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48.
Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]).
An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 48
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0
Time Frame: Week 0
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 0: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity visual analog scale (VAS), Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 0
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Percentage of Participants Achieving ACR20 Response at Week 4
Time Frame: Week 4
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 4: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 4
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Percentage of Participants Achieving ACR20 Response at Week 12
Time Frame: Week 12
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 12: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 12
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Percentage of Participants Achieving ACR20 Response at Week 24
Time Frame: Week 24
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 24: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 24
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Percentage of Participants Achieving ACR20 Response at Week 36
Time Frame: Week 36
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 36: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 36
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Percentage of Participants Achieving ACR20 Response at Week 48
Time Frame: Week 48
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 48: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 48
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Percentage of Participants Achieving ACR20 Response at Week 52
Time Frame: Week 52
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Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 52: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein).
Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
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Week 52
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Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0
Time Frame: Baseline (Lead-in Study), Week 0
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The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 0
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4
Time Frame: Baseline (Lead-in Study), Week 4
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The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 4
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12
Time Frame: Baseline (Lead-in Study), Week 12
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The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 12
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24
Time Frame: Baseline (Lead-in Study), Week 24
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The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 24
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36
Time Frame: Baseline (Lead-in Study), Week 36
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The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 36
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48
Time Frame: Baseline (Lead-in Study), Week 48
|
The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 48
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HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52
Time Frame: Baseline (Lead-in Study), Week 52
|
The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5.
Negative change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 52
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Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0
Time Frame: Baseline (Lead-in Study), Week 0
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 0
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4
Time Frame: Baseline (Lead-in Study), Week 4
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 4
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12
Time Frame: Baseline (Lead-in Study), Week 12
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 12
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24
Time Frame: Baseline (Lead-in Study), Week 24
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 24
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36
Time Frame: Baseline (Lead-in Study), Week 36
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 36
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48
Time Frame: Baseline (Lead-in Study), Week 48
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 48
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SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52
Time Frame: Baseline (Lead-in Study), Week 52
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The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1-4 comprise the physical component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 52
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SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0
Time Frame: Baseline (Lead-in Study), Week 0
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 0
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4
Time Frame: Baseline (Lead-in Study), Week 4
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 4
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12
Time Frame: Baseline (Lead-in Study), Week 12
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 12
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24
Time Frame: Baseline (Lead-in Study), Week 24
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 24
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36
Time Frame: Baseline (Lead-in Study), Week 36
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 36
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48
Time Frame: Baseline (Lead-in Study), Week 48
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 48
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SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52
Time Frame: Baseline (Lead-in Study), Week 52
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The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 5-8 comprise the mental component of the SF-36.
Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Baseline is defined as baseline in the lead-in study.
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Baseline (Lead-in Study), Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
- Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, Topp AS, Eldred A, Behrens F, Papp KA. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5.
Helpful Links
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 (Actual)
December 15, 2016
Primary Completion (Actual)
July 8, 2018
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 8, 2016
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 3, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M16-244
- 2016-003113-94 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission.
This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
For more information on the process, or to submit a request, visit the following link.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Psoriatic Arthritis
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AmgenRecruitingActive Juvenile Psoriatic ArthritisSpain, United Kingdom, Turkey, Belgium, France, Greece, Italy, Austria, Germany, Netherlands, Poland, Portugal, Romania, Lithuania, South Africa
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Universitätsklinikum Hamburg-EppendorfBristol-Myers Squibb; Eli Lilly and Company; UCB Pharma; Merck Sharp & Dohme LLC; AbbVi... and other collaboratorsRecruiting
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Bristol-Myers SquibbCompletedPsoriatic Arthritis (PsA)Germany
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Pope Research CorporationAmgenWithdrawn
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Sun Pharmaceutical Industries LimitedActive, not recruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Germany, India, Japan, Korea, Republic of, Poland, Spain
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AbbVieActive, not recruitingPsoriatic Arthritis (PsA)United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United...
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Sun Pharmaceutical Industries LimitedCompleted
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Bristol-Myers SquibbCompletedActive Psoriatic ArthritisSpain, United States, Hungary, Germany, Poland, United Kingdom, Russian Federation, Italy, Czechia
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Sun Pharmaceutical Industries LimitedRecruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Estonia, Korea, Republic of, Poland, Slovakia, Spain, Taiwan, Germany, Italy, India, Canada
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Humanis Saglık Anonim SirketiCompletedPsoriasis and Psoriatic ArthritisIndia
Clinical Trials on risankizumab
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Shaare Zedek Medical CenterNot yet recruitingCrohn Disease
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AbbVieActive, not recruitingCrohn's DiseaseUnited States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic... and more
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AbbVieActive, not recruiting
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AbbVieCompleted
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AbbVieCompletedCrohn's DiseaseUnited States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic... and more
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AbbViePPDRecruitingPlaque Psoriasis | Crohn Disease | Psoriatic Arthritis | Other Conditions for Which Risankizumab is an FDA-approved TreatmentUnited States
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AbbVieCompletedCrohn's DiseaseUnited States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic... and more
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AbbVieCompletedUlcerative Colitis (UC)United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Nether... and more
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AbbVieNot yet recruiting
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AbbVieNo longer availableCrohn's Disease | Ulcerative Colitis (UC)