ACTH Gel Therapy in Rheumatoid Arthritis
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/7/2019 |
| Start Date: | November 2014 |
| End Date: | March 2020 |
| Contact: | Laurie Hope, RN |
| Email: | hopelk@upmc.edu |
| Phone: | 412-647-2638 |
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.
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.
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis
and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each
week for 12 weeks as a supplement to current therapies. Subjects are required to visit the
clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a
blood sample for research purposes.
and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each
week for 12 weeks as a supplement to current therapies. Subjects are required to visit the
clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a
blood sample for research purposes.
Inclusion Criteria:
- 18 year of age and older
- RA diagnosis by American College of Rheumatology criteria
- Active disease (CDAI > 10)
- Have received at least are biologic agent for at least 6 months
- May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of
prednisone equivalent
- No current active infections requiring antibiotics
- Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA
therapies for at least 4 weeks prior to baseline visit)
Exclusion Criteria:
- Less than 18 years of age
- Unable or unwilling to give Informed Consent
- Have an active infection requiring the use of antibiotics
- Women who are pregnant
- Uncontrolled hypertension
- Abnormal renal function
- Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and
aspartate aminotransferase (AST) that is greater than 5 times normal.
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Larry W Moreland, MD
Phone: 412-647-2638
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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