Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.

• >= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

Exclusion Criteria:

• Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.

• Other rheumatic diseases.

• Active uveitis within 6 months of the baseline visit.

• Any other significant health problem.