CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 637 enrolled
Drug / intervention
Placebo injections +4 moredrug
Likely dose
Golimumab 50 mg injectionsfrom 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/NCT00264537
NCT00264537Phase 3Completed
CompareCT.gov

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

Centocor, Inc.·interventional·Posted Dec 13, 2005·Updated Sep 5, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo injections, Placebo capsules, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 637 participants across 75 sites in 21 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, Hungary, India, Malaysia, New Zealand, Philippines, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2005
Enrollment StartDec 1, 2005
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.6 years ago

Interventions

Placebo injectionsdrug

SC injections

Placebo capsulesdrug

Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).

Methotrexate capsulesdrug

Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.

Golimumab 50 mg injectionsbiological

SC injections

Golimumab 100 mg injectionsbiological

SC injections