CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
Adalimumab 80 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/NCT00538902
NCT00538902Phase 3Completed

A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Abbott·interventional·Posted Oct 3, 2007·Updated Apr 11, 2011

In Brief

A Phase 3 clinical trial evaluating Placebo, Adalimumab 80 mg, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 302 participants across 11 sites.

Detailed Summary

A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2007
Enrollment StartAug 1, 2007
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.7 years ago

Interventions

Placebobiological

Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.

Adalimumab 80 mgbiological

Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.

Adalimumab 40 mgbiological

Adalimumab 40 mg administered subcutaneously every other week for 104 weeks