CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 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/NCT01010503
NCT01010503Phase 4Completed
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Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

Hoffmann-La Roche·interventional·Posted Nov 10, 2009·Updated Aug 13, 2014

In Brief

A Phase 4 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2009
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.6 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

tocilizumab 8 mg/kg intravenous infusion once in 4 weeks