Trials / Completed
CompletedNCT01166282
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
A Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | adalimumab | Adalimumab solution for subcutaneous injection. |
| BIOLOGICAL | placebo for adalimumab | Placebo for adalimumab solution for subcutaneous injection. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2012-11-01
- Completion
- 2015-12-01
- First posted
- 2010-07-21
- Last updated
- 2021-07-12
- Results posted
- 2016-06-21
Source: ClinicalTrials.gov record NCT01166282. Inclusion in this directory is not an endorsement.