CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,032 enrolled
Drug / intervention
adalimumab +2 morebiological
Likely dose
adalimumab 40 mgfrom 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.

Search/NCT00420927
NCT00420927Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

Abbott·interventional·Posted Jan 11, 2007·Updated Apr 18, 2012

In Brief

A Phase 4 clinical trial evaluating adalimumab, methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,032 participants across 170 sites in 21 countries.

Detailed Summary

This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2007
Enrollment StartDec 1, 2006
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.5 years ago

Interventions

adalimumabbiological

Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

methotrexatedrug

Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.

placebobiological

Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)