CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 418 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra] +1 moredrug
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/NCT00754572
NCT00754572Phase 3Completed
CompareCT.gov

A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Hoffmann-La Roche·interventional·Posted Sep 18, 2008·Updated May 15, 2015

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] and methotrexate for Rheumatoid Arthritis. Completed, enrolled 418 participants across 69 sites in 10 countries.

Detailed Summary

This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Uruguay, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2008
Enrollment StartFeb 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.8 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

8mg/kg iv, every 4 weeks

methotrexatedrug

10-25mg oral or parenteral weekly.