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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00420199
Date of registration: 08/01/2007
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Scientific title: A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate
Date of first enrolment: May 2007
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00420199
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Austria Belgium Germany Netherlands Spain Sweden United Kingdom
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP)
>3.2 or >6 swollen and =6 tender joints and CRP greater than the upper limit of normal

- At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or
rheumatoid factor

- Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline

- Participants must have been treated with methotrexate, on a weekly dose of at least 15
mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before
screening. Dose of methotrexate must be stable for at least 28 days prior to the first
study dose (Day 1)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Active Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Placebo
Primary Outcome(s)
Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA [Time Frame: Baseline to Day 113]
Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis [Time Frame: Baseline to Day 113]
Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) [Time Frame: At baseline]
Secondary Outcome(s)
Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores [Time Frame: Baseline to Day 113]
Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores [Time Frame: Baseline to Day 113]
Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores [Time Frame: Baseline to Day 113]
Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores [Time Frame: At baseline]
Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores [Time Frame: At baseline]
Double-blind Period: Baseline Mean RAMRIS Scores [Time Frame: Baseline]
Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C]) [Time Frame: Baseline to Days 15, 29, 57, 85, and 113]
Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC]) [Time Frame: Baseline to Days 15, 29, 57, 85, and 113]
Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP]) [Time Frame: Baseline to Days 15, 29, 57, 85, and 113]
Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP) [Time Frame: Baseline to Days 15, 29, 57, 85, and 113]
Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With AEs of Special Interest [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Infections/Infestations of Special Interest [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality [Time Frame: From Day 1 to Day 113, and including up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis [Time Frame: Baseline to Day 113]
Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest [Time Frame: From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period]
Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay [Time Frame: Day 1 to Day 113]
Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs [Time Frame: Days 1, 15, 29, 57, 85, and 113]
Secondary ID(s)
Eudract: 2006-003768-67
IM101-119
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/05/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00420199
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