CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 444 enrolled
Drug / intervention
Golimumab 100 mg +4 moredrug
Likely dose
Golimumab 100 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/NCT00264550
NCT00264550Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy

Centocor, Inc.·interventional·Posted Dec 13, 2005·Updated Apr 29, 2014

In Brief

A Phase 3 clinical trial evaluating Golimumab 100 mg, Golimumab 50 mg, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 444 participants across 50 sites in 12 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Canada, Chile, Germany, Hungary, Mexico, New Zealand, Poland, South Korea, Taiwan, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2005
Enrollment StartDec 1, 2005
Primary CompletionSep 1, 2007
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.6 years ago

Interventions

Golimumab 100 mgdrug

Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.

Golimumab 50 mgdrug

Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.

Methotrexatedrug

Participants will receive methotrexate capsules weekly.

Placebo injectiondrug

Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.

Placebo capsulesdrug

Participants will receive placebo capsules weekly