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Study of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)

2014-08-27 03:55:41 | BioPortfolio

Summary

This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in subjects with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.

Description

The study design for this clinical trial was chosen to evaluate adalimumab in subjects who are either MTX-naïve (non-MTX stratum) or are inadequate responders or are intolerant to MTX (MTX stratum). All subjects who met entry criteria were enrolled into one of the appropriate strata and received adalimumab (plus concomitant MTX in the MTX stratum) in the 16 week open-label lead-in phase of the study. All subjects who responded to adalimumab during the open-label lead-in phase were to be enrolled in the double-blind phase of the study and randomized to receive adalimumab (plus concomitant MTX in the MTX stratum) or placebo (plus concomitant MTX in the MTX stratum). Adalimumab or placebo was administered for an additional 32 weeks or until flare of disease, whichever was earlier. For subjects who did not have a disease flare, the double-blind phase was completed at Week 48. Subjects who experienced disease flare during the double-blind phase or subjects who completed 48 weeks of the study were given the option to receive adalimumab for up to an additional 240 weeks in an open-label extension phase.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Arthritis, Juvenile Idiopathic

Intervention

Adalimumab, Placebo

Location

Birmingham
Alabama
United States
35294

Status

Active, not recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:41-0400

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ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis.

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Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

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A serious complication of childhood systemic inflammatory disorders that is thought to be caused by excessive activation and proliferation of T-LYMPHOCYTES and MACROPHAGES. It is seen predominantly in children with systemic onset JUVENILE IDIOPATHIC ARTHRITIS.

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