CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 592 enrolled
Drug / intervention
Golimumab +2 moredrug
Likely dose
Golimumab 2 mg/kgfrom 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/NCT00973479
NCT00973479Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Centocor, Inc.·interventional·Posted Sep 9, 2009·Updated Dec 25, 2013

In Brief

A Phase 3 clinical trial evaluating Golimumab, Placebo, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 592 participants across 88 sites in 13 countries.

Detailed Summary

The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Australia, Colombia, Hungary, Lithuania, Malaysia, Mexico, New Zealand, Poland, Russia, South Korea, Ukraine, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.8 years ago

Interventions

Golimumabdrug

Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).

Placeboother

Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.

methotrexate (MTX)drug

Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.