A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Study ID
- NCT01166282
- Phase
- PHASE3
- Status
- Completed
Conditions
- Enthesitis Related Arthritis (ERA)
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- adalimumab — BIOLOGICALAdalimumab solution for subcutaneous injection.
- placebo for adalimumab — BIOLOGICALPlacebo for adalimumab solution for subcutaneous injection.
Study Details
The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).
Key Dates
- Start date
- Sep 30, 2010
- Status verified
- Jul 2021
- Primary completion
- Nov 30, 2012
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 46 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Double-blind Placebo EOWPlacebo for adalimumab every other week (eow) for 12 weeks.
- Experimental: Double-blind Adalimumab EOWAdalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
- Experimental: Open-label Adalimumab EOWAdalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
Primary Outcome Measure
Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]