NCT00095173CompletedPhase 3
A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)
Bristol-Myers Squibb1 site in 1 country214 target enrollmentStarted: December 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)
Study Overview
Brief Summary
The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;
- •Current active arthritis;
- •Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);
- •Subjects must discontinue use of any DMARD other than methotrexate prior to the first dose of study medication
Exclusion Criteria
- •Presence of infection or history of frequent acute or chronic infections;
- •Joint replacement surgery required during the study or history of surgery on more than 5 joints;
- •Live vaccines within 3 months of the first dose of study medication;
- •Unresolved serious bacterial infection or chronic bacterial infection;
- •Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash, hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
Arms & Interventions
Abatacept
Active Comparator
Double Blind Period
Intervention: Abatacept (Drug)
Placebo
Placebo Comparator
Double Blind Period
Intervention: Placebo (Drug)
Abatacept - Open Label
Experimental
Intervention: Abatacept (Drug)
Outcomes
Primary Outcomes
Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)
Time Frame: Period B (Day 113 to Day 282)
Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)
Secondary Outcomes
- Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)(Period B (Day 113 to Day 282))
- Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)(Period A (Day 1 to Day 113))
- Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)(Period B (Day 113 to Day 282))
- Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)(Period C (Day 282 to end of study))
- Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)(Period B (Day 113 to Day 282))
- Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)(Period C (Day 282 to end of study))
- Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies(Period A (Day 1 to Day 113))
- Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies(Period B (Day 113 to Day 282))
- Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies(Period C (Day 282 up to 56 days after the last dose of study medication))
- Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate(Day 113, Day 282, and Day 2047)
- Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)(Period A (Day 1 to Day 113))
- Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)(Period B (Day 113 to Day 282))
- Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)(Period C (Day 282 to end of study))
- Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)(Period C (Day 282 to 85 days after the last dose of study medication))
Investigators
Study Sites (1)
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