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Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms. ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
Details
| Lead sponsor | Dana Ascherman |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2014-11 |
| Completion | 2022-06-30 |
Conditions
- Rheumatoid Arthritis
Interventions
- ACTHAR gel
Primary outcomes
- Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 — 12 weeks
percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
Countries
United States