Clinical trial
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy…
NCT00195663 · AbbVie (prior sponsor, Abbott), Industry · Completed
Key facts
| NCT number | NCT00195663 |
|---|---|
| Title | Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis |
| Official title | A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2… |
| Acronym | PREMIER |
| Lead sponsor | AbbVie (prior sponsor, Abbott), Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Early Rheumatoid Arthritis |
| Intervention type | Biological, Drug |
| Interventions | Adalimumab, Methotrexate, Adalimumab placebo, Methotrexate placebo |
| Enrollment | 799 |
| Start date | Dec 1, 2000 |
| Primary completion | Apr 1, 2004 |
| Completion | Apr 1, 2012 |
| First posted | Sep 20, 2005 |
| Last update posted | Jul 12, 2013 |
| Countries | Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands and 7 more |
At a glance
- 100–999 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: