At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
tocilizumab +1 moredrug
Likely dose
tocilizumab 8mg/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.
Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
In Brief
A Phase 2 clinical trial evaluating tocilizumab and placebo for Dermatomyositis and Polymyositis. Completed, enrolled 36 participants across 7 sites.
Detailed Summary
The purpose of this multi-center pilot study is to determine if the drug tocilizumab (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM) and dermatomyositis (DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis, Polymyositis
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartOct 2014
Primary CompletionJul 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJan 23, 2014
Enrollment StartOct 1, 2014
Primary CompletionJul 30, 2019
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.4 years ago
Interventions
tocilizumabdrug
given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).
placebodrug
given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).