Overview

This trial is active, not recruiting.

Condition juvenile idiopathic arthritis
Treatment abatacept
Phase phase 3
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharmaceutical Co. Ltd
Start date August 2013
End date November 2015
Trial size 20 participants
Trial identifier NCT01835470, IM101-365

Summary

The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
abatacept BMS-188667

Primary Outcomes

Measure
American College of Rheumatology (ACR) Pediatric 30 response rate
time frame: Week 16 (Day 113)

Secondary Outcomes

Measure
ACR pediatric 50, 70 and 90 response rates
time frame: Week 16 (Day 113)
Inactive disease rate
time frame: Week 16 (Day 113)
Disability index of the Childhood Health Assessment Questionnaire (CHAQ)
time frame: Week 16 (Day 113)
Safety summarized by proportion of subjects with Adverse Events (AEs), deaths, Serious Adverse Events (SAEs), and AEs of special interest
time frame: Up to Week 16 (Day 113) - Short term (ST) period
Maximum observed concentration (Cmax) of Abatacept
time frame: 9 time points up to Week 16 (Day 113) - ST period
Trough observed concentration (Ctrough) of Abatacept
time frame: 9 time points up to Week 16 (Day 113) - ST period
Immunogenicity positive rates
time frame: Up to Week 16 (Day 113) - ST period

Eligibility Criteria

Male or female participants from 4 years up to 17 years old.

Inclusion Criteria: - Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or Methotrexate (MTX). - Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course. - Men and women, ages 4 to 17 years, inclusive at enrollment. - Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by: 1. ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening and at Week 0 (Day 1). 2. ≥2 joints with LOM at screening and at Week 0 (Day 1). Exclusion Criteria: - Systemic onset JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome. - Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)

Additional Information

Official title A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.