At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 121 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.
A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 121 participants across 8 sites.
Detailed Summary
This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesMorocco
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
Primary CompletionAug 2011
First PostedJun 2012
TodayJul 2026
First PostedJun 4, 2012
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.1 years ago
Interventions
tocilizumab [RoActemra/Actemra]drug
8 mg/kg iv every 4 weeks, total of 6 infusions