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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

STUDY PHASE III, MULTICENTER, INTERNATIONAL, RANDOMIZED, SUSPENSION, TO EVALUATE THE SAFETY AND EFFICACY OF BMS-188667 IN CHILDREN AND ADOLESCENTS WITH RHEUMATOID ARTHRITIS YOUTH POLIARTICULAR (ARJ)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-012-04
Enrollment
Unknown
Registered
2004-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

BMS-188667 Type of group
BMS-188667 is administered in an open dose beginning on Day A1, then aleatorized and BMS-188667 is administered. Group name:placebo Type of group
BMS-188667 is administered in an open dose beginning on Day A1, then aleatorized and placebo is administered from BMS-188667

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of juvenile rheumatoid arthritis or juvenile idiopathic arthritis; Current active arthritis; Failed treatment with at least one disease modifying antirheumatic drug (DMARD); Subjects should discontinue the use of any DMARD other than methotrexate before the first dose of study medication

Exclusion criteria

Exclusion criteria: Presence of infection or a history of frequent acute or chronic infections; Joint replacement surgery required during the study or history of surgery in more than 5 joints; Live vaccines within 3 months of the first dose of the study medication; Severe unresolved bacterial infection or chronic bacterial infection; Subjects who currently have intermittent fever due to ARJ / JIA, rheumatoid exanthema, hepato-splenomegaly, pleuritis, pericarditis or macrophage activation syndrome.

Design outcomes

Primary

MeasureTime frame
Outcome name:Number of active joints, number of joints with a limited range of mobility, overall physical assessment of the severity of the disease according to the doctor, overall assessment related to the general well-being performed by a parent Measure:Clinical response of BMS-188667 versus placebo will be the comparison of time until occurrence of exacerbation of the ARJ / AJI during the period of double blind treatment Timepoints:6 month—

Secondary

MeasureTime frame
Outcome name:Number of active joints, number of joints with a limited range of mobility, overall physical assessment of the severity of the disease according to the doctor, overall assessment related to the general well-being performed by a parent Measure:proportion of subjects demonstrating exacerbation of the ARJ / AJI to Day B 169 will be used to assess the clinical response. Timepoints:6 month—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)