CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 656 enrolled
Drug / intervention
Tocilizumab 162 mg +1 moredrug
Likely dose
Tocilizumab 162 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/NCT01232569
NCT01232569Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Hoffmann-La Roche·interventional·Posted Nov 2, 2010·Updated Jul 29, 2015

In Brief

A Phase 3 clinical trial evaluating Tocilizumab 162 mg and Placebo for Rheumatoid Arthritis. Completed, enrolled 656 participants across 141 sites in 22 countries.

Detailed Summary

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Colombia, Greece, Guatemala, Hungary, Israel, Malaysia, Mexico, New Zealand, Panama, Philippines, Poland, Russia, South Africa, Spain, Switzerland, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2010
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2012
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.7 years ago

Interventions

Tocilizumab 162 mgdrug

Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.

Placebodrug

Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.