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NCT02728752 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
A Phase 3 study of Dermatomyositis, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT02728752: Completed Phase 3 study of Dermatomyositis, sponsored by Octapharma.
NCT02728752 is a Phase 3 study of Dermatomyositis that has completed, run by Octapharma. The registered enrollment target is 95 participants, below the 480-participant average among 19 other Dermatomyositis trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02728752, a Phase 3 study of Dermatomyositis, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
Primary Outcome
Proportion of responders in the 2.0 g/kg Octagam 10% and placebo arms at Week 16 relative to baseline (Week 0). A responder being defined as a patient with an increase of ≥20 points on the Total Improvement Score (TIS, a scale from 0 to 100; 20-39 points being minimal improvement, 40-59 points being moderate improvement, and ≥60 points being major improvement
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Octagam 10%
Study Locations (20)
Florida
- Octapharma Research Site - Orlando
- NeuroMedical Research Center - Panama City
- Octapharma Research Site - Plantation
- University of South Florida - Tampa
California
- Octapharma Research Site - Huntington Beach
- Octapharma Research Site - Los Angeles
- University of California -Irvine - Orange
Texas
- Austin Neuromuscular Center - Austin
- Octapharma Research Site - Houston
- Arthritis & Osteoporosis Clinic - Waco
Other
- Revmatologický ústav - Prague
- Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie - Berlin
Kansas
- Octapharma Research Site - Kansas City
Michigan
- Octapharma Research Site - Ann Arbor
Minnesota
- Octapharma Research Site - Rochester
New York
- Octapharma Research Site - Great Neck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-02-27 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 3 |
What the finished NCT02728752 record still lists
NCT02728752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 480-participant average among 19 other Dermatomyositis trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02728752 names 20 study sites across 12 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02728752 about?
NCT02728752 is a clinical study titled "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")
What is the current status of trial NCT02728752?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2017-02-27. Estimated completion is 2019-11-05.
What conditions does trial NCT02728752 study?
This clinical trial studies the following conditions: Dermatomyositis.
What interventions are being tested in trial NCT02728752?
The interventions under investigation include: Placebo (OTHER), Octagam 10% (DRUG).
Who is sponsoring clinical trial NCT02728752?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02728752 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatomyositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02728752's enrollment target sits among peer trials
95 10th of 19 higher than 10 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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