ACTH Gel Therapy in Rheumatoid Arthritis

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

Sponsors

Lead Sponsor: Dana Ascherman

Collaborator: Mallinckrodt

Source University of Pittsburgh
Brief Summary

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.

Detailed 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.

Overall Status Recruiting
Start Date November 2014
Completion Date August 31, 2021
Primary Completion Date May 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Clinical Disease Activity Index 12 weeks
Secondary Outcome
Measure Time Frame
Change in the Disease Activity Score 12 weeks
Changes in acute phase reactants 12 weeks
Patient reported changes in fatigue 12 weeks
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: ACTHAR gel

Description: Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.

Arm Group Label: ACTHAR Gel

Other Name: Adrenocorticotropic hormone

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Larry W Moreland, MD Principal Investigator University of Pittsburgh
Overall Contact

Last Name: Laurie Hope, RN

Phone: 412-647-2638

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Pittsburgh Laurie Hope, RN 412-647-2638 [email protected] Larry W Moreland, MD Principal Investigator
Location Countries

United States

Verification Date

November 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Pittsburgh

Investigator Full Name: Dana Ascherman

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: ACTHAR Gel

Type: Other

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov