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NCT02245841 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT02245841: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT02245841 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02245841, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis, and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and effective for such patients.
Primary Outcome
Change between baseline at 6 months in modified CDASI-A (Cutaneous Dermatomyositis Disease Area and Severity Index) scores at these timepoints. The CDASI-A score ranges from 0 to 100 with higher scores reflecting more severe disease activity.
Interventions
- DRUG H.P. Acthar Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-06-15 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 4 |
What the finished NCT02245841 record still lists
NCT02245841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which H.P. Acthar Gel is the first listed.
NCT02245841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02245841 about?
NCT02245841 is a clinical study titled "Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis". This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis, and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and effective for such p...
What is the current status of trial NCT02245841?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2015-06-15. Estimated completion is 2021-07-14.
What interventions are being tested in trial NCT02245841?
The interventions under investigation include: H.P. Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT02245841?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02245841's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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