CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra]drug
Likely dose
tocilizumab [RoActemra/Actemra] 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/NCT01326962
NCT01326962Phase 3Completed
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Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

Hoffmann-La Roche·interventional·Posted Mar 31, 2011·Updated Aug 16, 2017

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 28 participants across 4 sites.

Detailed Summary

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2011
Enrollment StartNov 30, 2011
Primary CompletionMay 12, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.3 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions