Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis

STUDY19050342

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.

2014-11-01

2022-06-30

2022-06-30

Completed

18

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2023-09-06