CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 264 enrolled
Drug / intervention
Golimumab +2 moredrug
Likely dose
Golimumab 50 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/NCT01248780
NCT01248780Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Centocor, Inc.·interventional·Posted Nov 25, 2010·Updated Sep 6, 2013

In Brief

A Phase 3 clinical trial evaluating Golimumab, Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 264 participants across 9 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesChina
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2011
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.6 years ago

Interventions

Golimumabdrug

50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks

Placebodrug

Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.

Methotrexate (MTX)drug

A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.