Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER)

Pfizer

Status and phase

Completed

Phase 3

Conditions

Arthritis, Juvenile Idiopathic

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00962741

0881A1-3338

B1801014

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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.