CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 643 enrolled
Drug / intervention
Golimumab +2 moredrug
Likely dose
Golimumab 2mg/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/NCT00361335
NCT00361335Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Centocor, Inc.·interventional·Posted Aug 8, 2006·Updated Jul 29, 2014

In Brief

A Phase 3 clinical trial evaluating Golimumab, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 643 participants across 72 sites in 15 countries.

Detailed Summary

The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Colombia, Germany, Hungary, Latvia, Lithuania, Malaysia, Malta, Mexico, New Zealand, Peru, Poland, Ukraine, United States
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2006
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2007
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.9 years ago

Interventions

Golimumabdrug

2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes

Methotrexatedrug

Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.

Placebodrug

Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.