Study evaluating safety and effectiveness in children with childhood arthritis

• Conditions: Juvenile idiopathic arthritis (JIA); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-001171-37-Outside-EU/EEA
• Lead Sponsor: Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 594

Inclusion Criteria

•Boys or girsl agew 2 to 18 years (inclusive) with a diagnosis of systemic, polyarticular, or pauciarticular JRA defined by the American College of Rheumatology (ACR) criteria.
•Duration of disease long enough for the subject to have been given an adequate trial of nonsteroidal anti-inflammatory drug (NSAID) and/or prednisolone.
•Co-administration of other DMARDS that did not specifically inhibit TNF (eg: infliximab, thalidomide, D2E7 [adalimumab]).
•Parent or legal guardian able and willing to give informed consent.
•Disease course must have been polyarticular or systemic with active arthritis in greater than or equal to 3 joints at the time of starting methotrexate alone or methotrexate in combination with other DMARDS, etanercept alone or etanercept added to ongoing methotrexate or other DMARDS.
•Pre-pubescent, or if post-pubertal at any time during the study and of childbearing potential must practice adequate contraception
Etanercept Arm
•Newly started etanercept or began etanercept within 6 months of enrollment into the study. Subjects who entered the study from selected Immunex protocols and may have received etanercept for up to 1 year had their time of exposure counted from the first dose of etanercept in the original Immunex study.
Methotrexate Arm
•Newly started methotrexate or began methotrexate within 6 months of enrollment into the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 583
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or nursing
•Receipt of antibody to TNF (infliximab, adalimumab, or other anti-TNF), antibody to CD4 (anti CD4), or diphtheria interlukin-2 fusion protein (DAB-IL-2).
•Participation in a study of an investigational drug or biologic other than etanercept that required informed consent = 6 months.
•Receipt of any of the following DMARDS: TNF inhibitors other than etanercept such as infliximab, thalidomide, adalimumab, cyclophosphamide, experimental agents; or other biologic agents
•Any serious concurrent medical condition, either acute or chronic, which would compromise the subject’s ability to cooperate with the protocol requirements.
•History of alcohol or drug abuse
•Prior malignancies unless the subject had been disease-free for at least 5 years.
•Serious concurrent medical conditions, either acute or chronic (including infections) that prevent the subject from receiving a TNF inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified