A multicenter study of the safety, efficacy effects on the body of Humira (adalimumab) in children with polyarticular Juvenile Rheumatoid Arthritis (a form of reheumatoid arthritis in children / young people with unknown cause).

• Conditions: Polyarticular Juvenile Rheumatoid Arthritis; MedDRA version: 14.1Level: LLTClassification code 10036039Term: Polyarticular juvenile rheumatoid arthritis, chronic or unspecifiedSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-001661-40-Outside-EU/EEA
• Lead Sponsor: Abbott Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

•Subjects must have a diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects must be free of any systemic JRA manifestations for at least 3 months before the time of qualification.
•At the time of study screening, the subject must have continuing active disease defined as >= 5 swollen joints and >= 3 joints with limitation of motion (LOM). These joints are not mutually exclusive.
•Subjects may be either naïve to MTX, inadequate responders to MTX, or intolerant to MTX. Intolerance to MTX will be defined by the subject's physician. The MTX must be maintained at a dose of at least 10 mg/m2 body surface area/week for a minimum of 3 months, prior to screening.
•Duration of disease is not limited, but must have been long enough for a subject to have been given an adequate trial of nonsteroidal anti-inflammatory drugs (NSAIDs).

Are the trial subjects under 18? yes
Number of subjects for this age range: 171
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or nursing female.
•Functional class IV by ACR criteria.
•Laboratory parameters outside limits established in the protocol.
•Medical history, medical condition, or previous treatment not allowed by the protocol.

Study & Design

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