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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis
This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
Details
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 171 |
| Start date | 2002-09 |
| Completion | 2010-06 |
Conditions
- Arthritis, Juvenile Idiopathic
Interventions
- Double-Blind Adalimumab/Placebo + MTX
- Double-Blind Adalimumab/Placebo
- OLE BSA Adalimumab +/- MTX
- OLE FD Adalimumab +/- MTX
Primary outcomes
- Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase — Week 16 to Week 48 (32 weeks)
The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more than 1 of the 6 JRA core set criteria.
Countries
United States, Belgium, Czechia, France, Germany, Italy, Slovakia, Spain