ACTH Gel Therapy in Rheumatoid Arthritis

Dana Ascherman

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: ACTHAR gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02030028

STUDY19050342

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

ACTHAR Gel

Other group

Description:

Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.

Treatment:

Drug: ACTHAR gel