- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758198
Abatacept Post-marketing Clinical Study in Japan
May 12, 2017 updated by: Bristol-Myers Squibb
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
405
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Asahi, Japan, 289-2511
- Local Institution
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Fuchu, Japan, 183-8524
- Local Institution
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Fukuoka, Japan, 810-8563
- Local Institution
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Fukuoka, Japan, 813-0017
- Local Institution
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Funabashi, Japan, 274-0053
- Local Institution
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Hakodate, Japan, 040-8611
- Local Institution
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Hiroshima, Japan, 734-8551
- Local Institution
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Hitachi, Japan, 316-0015
- Local Institution
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Hokkaido, Japan, 078-8243
- Local Institution
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Iizuka, Japan, 820-8505
- Local Institution
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Kagoshima, Japan, 890-0067
- Local Institution
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Kagoshima, Japan, 891-0133
- Local Institution
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Kanazawa, Japan, 920-8616
- Local Institution
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Kasama, Japan, 309-1793
- Local Institution
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Kato, Japan, 673-1462
- Local Institution
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Kitakyushu, Japan, 800-0031
- Local Institution
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Kitakyushu, Japan, 800-0296
- Local Institution
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Kitakyushu, Japan, 807-8556
- Local Institution
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Kitamoto, Japan, 364-8501
- Local Institution
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Kobe, Japan, 650-0017
- Local Institution
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Kobe, Japan, 654-0047
- Local Institution
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Kochi, Japan, 781-0112
- Local Institution
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Koshi, Japan, 861-1196
- Local Institution
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Kumamoto, Japan, 862-0976
- Local Institution
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Matsumoto, Japan, 390-8601
- Local Institution
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Nagano, Japan, 380-8582
- Local Institution
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Nagaoka, Japan, 940-2085
- Local Institution
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Nagasaki, Japan, 850-0832
- Local Institution
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Nagoya, Japan, 460-0001
- Local Institution
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Nagoya, Japan, 466-8560
- Local Institution
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Narashino, Japan, 275-0006
- Local Institution
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Narita, Japan, 286-0041
- Local Institution
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Okayama, Japan, 700-8607
- Local Institution
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Osaka, Japan, 545-8585
- Local Institution
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Osaki, Japan, 989-6183
- Local Institution
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Oume, Japan, 198-0042
- Local Institution
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Sapporo, Japan, 001-0907
- Local Institution
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Sapporo, Japan, 060-0001
- Local Institution
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Sapporo, Japan, 060-8648
- Local Institution
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Sapporo, Japan, 063-0811
- Local Institution
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Sasebo, Japan, 857-1195
- Local Institution
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Sayama, Japan, 350-1305
- Local Institution
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Sendai, Japan, 980-6116
- Local Institution
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Sendai, Japan, 982-0032
- Local Institution
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Sendai, Japan, 983-8512
- Local Institution
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Shizuoka, Japan, 420-0821
- Local Institution
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Takaoka, Japan, 933-0874
- Local Institution
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Takasaki, Japan, 370-0053
- Local Institution
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Tokyo, Japan, 101-0062
- Local Institution
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Tokyo, Japan, 104-8560
- Local Institution
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Tokyo, Japan, 130-8575
- Local Institution
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Tokyo, Japan, 160-8582
- Local Institution
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Tokyo, Japan, 162-8543
- Local Institution
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Tokyo, Japan, 162-8655
- Local Institution
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Tokyo, Japan, 170-8476
- Local Institution
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Tokyo, Japan, 173-8610
- Local Institution
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Tokyo, Japan, 174-0071
- Local Institution
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Tokyo, Japan, 179-0072
- Local Institution
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Tomakomai, Japan, 053-0018
- Local Institution
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Toyama, Japan, 930-0138
- Local Institution
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Toyama, Japan, 930-0194
- Local Institution
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Utsunomiya, Japan, 321-0964
- Local Institution
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Yokohama, Japan, 231-8682
- Local Institution
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Yokohama, Japan, 236-0004
- Local Institution
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Yotsukaido, Japan, 284-0003
- Local Institution
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Chiba
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Kamogawa-city, Chiba, Japan, 296-8602
- Local Institution
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Gifu
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Kasamatsu-town, Gifu, Japan, 501-6061
- Local Institution
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Hyogo
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Kakogawa-city, Hyogo, Japan, 675-8611
- Local Institution
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Kanagawa
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Yokohama-city, Kanagawa, Japan, 245-8575
- Local Institution
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Okayama
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Kurashiki-city, Okayama, Japan, 710-8602
- Local Institution
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Osaka
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Izumisano-city, Osaka, Japan, 598-0048
- Local Institution
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Shizuoka
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Fujieda-city, Shizuoka, Japan, 426-8677
- Local Institution
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Toyama
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Toyama-city, Toyama, Japan, 930-8550
- Local Institution
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Yamaguchi
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Shimonoseki-city, Yamaguchi, Japan, 750-8520
- Local Institution
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- MTX inadequate responder
- Biologic Naïve
- Functional class I, II or III
- ≥6 swollen and ≥6 tender joints
- C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- Anti-cyclic citrullinated peptide (CCP) antibody positive
- Have erosion
Exclusion Criteria:
- Any other rheumatic disease
- Active angiitis on main organs excluding rheumatoid nodule
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Abatacept + Methotrexate (MTX)
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months |
Other Names:
|
Placebo Comparator: Group 2: Placebo matching with Abatacept + Methotrexate
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
American College of Rheumatology (ACR) 20% response rate
Time Frame: 4 months (week 16)
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4 months (week 16)
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Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
Time Frame: Baseline (Day 1), 6 months (Week 24)
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Baseline (Day 1), 6 months (Week 24)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)
Time Frame: Baseline (Day 1), 4 months (Week 16)
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Baseline (Day 1), 4 months (Week 16)
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Non-progressors rate for the structural damage
Time Frame: Baseline (Day 1), 6 months (Week 24)
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The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)
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Baseline (Day 1), 6 months (Week 24)
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ACR 50 response rates
Time Frame: 4 months (Week16)
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4 months (Week16)
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ACR 70 response rates
Time Frame: 4 months (Week16)
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4 months (Week16)
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Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities
Time Frame: 12 months (Week52)
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12 months (Week52)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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)
April 11, 2013
Primary Completion (Actual)
December 26, 2016
Study Completion (Actual)
December 26, 2016
Study Registration Dates
First Submitted
December 19, 2012
First Submitted That Met QC Criteria
December 26, 2012
First Posted (Estimate)
January 1, 2013
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Immune Checkpoint Inhibitors
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Abatacept
Other Study ID Numbers
- IM101-338
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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