Clinical trial
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With…
NCT00048542 · Abbott, Industry · Completed
Key facts
| NCT number | NCT00048542 |
|---|---|
| Title | Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA) |
| Official title | 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 |
| Lead sponsor | Abbott, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Arthritis, Juvenile Idiopathic |
| Intervention type | Biological, Drug |
| Interventions | Double-Blind Adalimumab/Placebo + MTX, Double-Blind Adalimumab/Placebo, OLE BSA Adalimumab +/- MTX, OLE FD Adalimumab +/- MTX |
| Enrollment | 171 |
| Start date | Sep 1, 2002 |
| Primary completion | Jan 1, 2005 |
| Completion | Jun 1, 2010 |
| First posted | Nov 5, 2002 |
| Last update posted | Aug 22, 2011 |
| Countries | Belgium, Czechia, France, Germany, Italy, Slovakia, Spain, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: