CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 334 enrolled
Drug / intervention
Double-blind adalimumab +3 morebiological
Likely dose
Double-blind 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/NCT00870467
NCT00870467Phase 3Completed
CompareCT.gov

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

Abbott·interventional·Posted Mar 27, 2009·Updated Aug 7, 2012

In Brief

A Phase 3 clinical trial evaluating Double-blind adalimumab, Double-blind Placebo, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 334 participants across 88 sites.

Detailed Summary

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsEisai Co., Ltd.

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.3 years ago

Interventions

Double-blind adalimumabbiological

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

Double-blind Placebodrug

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

Open-label Adalimumabbiological

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

Open-labelAdalimumabRescuebiological

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26