At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 799 enrolled
Drug / intervention
Adalimumab +3 morebiological
Likely dose
Adalimumab every second week (biweekly) with methotrexate weekly or in combinationAI-extracted
Key inclusion· 6
- ✓Age ≥18 years
- ✓Diagnosis of rheumatoid arthritis per 1987-revised ACR criteria with disease duration <3 years
- ✓At least 8 swollen joints out of 66 assessed
- ✓At least 10 tender joints out of 68 assessed
Key exclusion· 5
- ✕Chronic arthritis diagnosed before age 16
- ✕Prior treatment with methotrexate, cyclophosphamide, cyclosporin, or azathioprine
- ✕Prior treatment with more than 2 other DMARDs
- ✕Prior anti-TNF therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Years in Patients With Early Rheumatoid Arthritis (PREMIER).
In Brief
A Phase 3 clinical trial evaluating Adalimumab, Methotrexate, and 2 other interventions for Early Rheumatoid Arthritis. Completed, enrolled 799 participants across 123 sites in 19 countries.
Detailed Summary
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Rheumatoid Arthritis
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2000
Primary CompletionApr 2004
First PostedSep 2005
Study CompletionApr 2012
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartDec 1, 2000
Primary CompletionApr 1, 2004
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago
Interventions
Adalimumabbiological
Methotrexatedrug
Adalimumab placebobiological
Methotrexate placebodrug