At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 420 enrolled
Drug / intervention
adalimumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
In Brief
A Phase 3 clinical trial evaluating adalimumab and Placebo for Rheumatoid Arthritis. Completed, enrolled 420 participants across 86 sites in 6 countries.
Detailed Summary
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Canada, Germany, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedMar 2008
Primary CompletionApr 2009
TodayJul 2026
First PostedMar 31, 2008
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
adalimumabdrug
Pre-filled syringe. See arm for more detail
Placebodrug
Pre-filled syringe. See arm for more detail
adalimumabdrug
Pre-filled syringe. See arm for more detail