At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of polyarticular JIA by ACR criteria; age 4–17 years. Disease onset may have been systemic, polyarticular, or pauciarticular; if systemic onset, must be free of systemic manifestations for ≥3 months.
- ✓Active disease at screening: ≥5 swollen joints AND ≥3 joints with limitation of motion.
- ✓Naive to MTX, inadequate responder to MTX, or intolerant to MTX. If on MTX, must be maintained at ≥10 mg/m² BSA/week for ≥3 months prior to screening.
- ✓Must have received an adequate trial of NSAIDs.
- ✕Pregnant or nursing female.
- ✕ACR functional class IV.
- ✕Laboratory parameters outside limits established in the protocol.
- ✕Medical history, condition, or previous treatment not allowed by the protocol.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Double-Blind Adalimumab/Placebo + MTX, Double-Blind Adalimumab/Placebo, and 2 other interventions for Arthritis, Juvenile Idiopathic. Completed, enrolled 171 participants across 31 sites in 8 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.
Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.
Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.
Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.