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NCT02298491 · ClinicalTrials.gov registry record · Phase 4
Treatment of CNS Sarcoidosis With H.P. Acthar Gel
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT02298491: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT02298491 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02298491, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be also associated with improvement in measures of quality of life. The treatment of CNS sarcoidosis involves the use of either corticosteroids such as prednisone or potent immunosuppressive agents such as methotrexate, both which can induce severe long term side effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have not been previously studied. In addition, little is known regarding the expression of immune markers in CNS sarcoidosis and the association of such markers with disease activity and response to treatment.
Primary Outcome
The Karnofsky Performance Scale score allows patients to be classified as to their functional impairment. This can be used to compare the effectiveness of different therapies and to assess the prognosis in individual patients. The scale ranges from 0 to 100. Higher scores are associated with better outcomes.
Interventions
- DRUG H.P. Acthar Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-05 |
| Est. Completion | 2020-11 |
| Phase | Phase 4 |
What the finished NCT02298491 record still lists
NCT02298491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which H.P. Acthar Gel is the first listed.
NCT02298491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02298491 about?
NCT02298491 is a clinical study titled "Treatment of CNS Sarcoidosis With H.P. Acthar Gel". The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be also associated with i...
What is the current status of trial NCT02298491?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2016-05. Estimated completion is 2020-11.
What interventions are being tested in trial NCT02298491?
The interventions under investigation include: H.P. Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT02298491?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02298491's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 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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