Trials / Completed
CompletedNCT02728752
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM Study")
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Octagam 10% | Patients to be treated with Octagam 10% |
| OTHER | Placebo | Patients to be treated with a Placebo |
Timeline
- Start date
- 2017-02-27
- Primary completion
- 2019-11-05
- Completion
- 2019-11-05
- First posted
- 2016-04-05
- Last updated
- 2021-12-23
- Results posted
- 2021-04-21
Locations
37 sites across 10 countries: United States, Canada, Czechia, Germany, Hungary, Netherlands, Poland, Romania, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02728752. Inclusion in this directory is not an endorsement.