Phase 3
Completed N=190
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00095173 ↗
Enrolled (actual)
190
Serious AEs
19.5%
Results posted
Jan 2017
Primary outcomePrimary: Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) — NA; 6 months — p=0.0002
◆ Published Evidence
Established
88citations · ~8 / year
Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.
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.
Linked Publications (5)
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Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.
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Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials.
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Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis.
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Probability of Response in the First Sixteen Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials.
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Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) |
NA; 6 | 0.0002 sig |
| SECONDARY Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) |
12; 33 | <0.001 sig |
| SECONDARY 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) |
6; 0; 0; 0; 1 | — |
| SECONDARY 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) |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY 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) |
9; 9; 12; 2; 4; 3 | — |
| SECONDARY Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B) |
-20.9; 50.00; 0.00; 50.00; -29.8; 55.95 | — |
| SECONDARY Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C) |
-26.7; -70.2; -82.4; 0.00; -50.0; -71.4 | — |
| SECONDARY Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies |
68; 30; 2; 0 | — |
| SECONDARY Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies |
27; 27; 2; 2; 0; 0 | — |
| SECONDARY Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies |
120; 22; 7; 1 | — |
| SECONDARY 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 |
0; 100; 100; NA; 84.5; 67.8 | — |
| SECONDARY Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A) |
2; 2; 1; 1; 2; 9 | — |
| SECONDARY Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B) |
1; 1; 1; 1; 0; 1 | — |
| SECONDARY Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C) |
12; 8; 4; 4; 5; 20 | — |
| SECONDARY Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C) |
1; 5; 2; 0; 3; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00095173) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.