CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 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/NCT01245439
NCT01245439Phase 3Completed
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Local 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

Hoffmann-La Roche·interventional·Posted Nov 22, 2010·Updated Nov 3, 2015

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 65 participants across 17 sites.

Detailed Summary

This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 22, 2010
Enrollment StartSep 1, 2011
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.6 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

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