CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra] +1 moredrug
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/NCT01353859
NCT01353859Phase 3Completed
CompareCT.gov

An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Hoffmann-La Roche·interventional·Posted May 16, 2011·Updated Jun 6, 2014

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] and methotrexate for Rheumatoid Arthritis. Completed, enrolled 39 participants across 5 sites.

Detailed Summary

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.1 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

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

methotrexatedrug

10-25 mg orally weekly