CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,080 enrolled
Drug / intervention
Etanercept +1 moredrug
Likely dose
Etanercept 50 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/NCT01331837
NCT01331837Phase 4Completed
CompareCT.gov

A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Hoffmann-La Roche·interventional·Posted Apr 8, 2011·Updated Jul 13, 2017

In Brief

A Phase 4 clinical trial evaluating Etanercept and Tocilizumab for Rheumatoid Arthritis. Completed, enrolled 3,080 participants across 428 sites in 31 countries.

Detailed Summary

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Austria, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Czechia, Ecuador, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2011
Enrollment StartAug 2, 2011
Primary CompletionMar 25, 2016
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.2 years ago

Interventions

Etanerceptdrug

Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Tocilizumabdrug

Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.