Phase 3 N=190 Randomized Double-blind Treatment

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00095173 ↗

Enrolled (actual)

190

Serious AEs

19.5%

Results posted

Jan 2017

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Abatacept (Drug); Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jun 2006

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00095173). 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.