CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,681 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra]drug
Likely dose
tocilizumab [RoActemra/Actemra] 8mg/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/NCT00750880
NCT00750880Phase 3Completed
CompareCT.gov

International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.

Hoffmann-La Roche·interventional·Posted Sep 11, 2008·Updated Jul 22, 2015

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 1,681 participants across 282 sites in 25 countries.

Detailed Summary

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.8 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

8mg/kg iv (60 minute infusion)