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NCT01906372 · ClinicalTrials.gov registry record · Phase 2
Acthar in Treatment of Refractory Dermatomyositis and Polymyositis
A Phase 2 study, sponsored by Rohit Aggarwal, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01906372: Completed Phase 2 study, sponsored by Rohit Aggarwal, MD.
NCT01906372 is a Phase 2 study that has completed, run by Rohit Aggarwal, MD. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906372, a Phase 2 study, has completed, sponsored by Rohit Aggarwal, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness without a rash. The study doctors want to evaluate whether ACTH Gel will improve the symptoms of this disease. This drug is approved by the Food and Drug Administration (FDA) for dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment for myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for ACTH gel use.
Primary Outcome
3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures.
Interventions
- DRUG Adrenocorticotropic Hormone Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT01906372 record still lists
NCT01906372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Adrenocorticotropic Hormone Gel is the first listed.
NCT01906372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01906372 about?
NCT01906372 is a clinical study titled "Acthar in Treatment of Refractory Dermatomyositis and Polymyositis". The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness without a rash. The study docto...
What is the current status of trial NCT01906372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01906372?
The interventions under investigation include: Adrenocorticotropic Hormone Gel (DRUG).
Who is sponsoring clinical trial NCT01906372?
This trial is sponsored by Rohit Aggarwal, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01906372's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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