At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
Octagam 10% +1 moredrug
Likely dose
Not stated in 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.
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM Study")
In Brief
A Phase 3 clinical trial evaluating Octagam 10% and Placebo for Dermatomyositis. Completed, enrolled 95 participants across 37 sites in 10 countries.
Detailed Summary
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis
CountriesCanada, Czechia, Germany, Hungary, Netherlands, Poland, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartFeb 2017
Primary CompletionNov 2019
TodayJul 2026
First PostedApr 5, 2016
Enrollment StartFeb 27, 2017
Primary CompletionNov 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.2 years ago
Interventions
Octagam 10%drug
Patients to be treated with Octagam 10%
Placeboother
Patients to be treated with a Placebo