CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
tocilizumab [RoActemra]drug
Likely dose
tocilizumab [RoActemra] 8 mg/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/NCT01254331
NCT01254331Phase 3Completed
CompareCT.gov

Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs

Hoffmann-La Roche·interventional·Posted Dec 6, 2010·Updated Feb 26, 2015

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra] for Rheumatoid Arthritis. Completed, enrolled 51 participants across 6 sites.

Detailed Summary

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesTunisia
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2010
Enrollment StartFeb 1, 2011
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.6 years ago

Interventions

tocilizumab [RoActemra]drug

tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions