Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis, Juvenile Idiopathic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Interventions

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Etanercept

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No