ACTH Gel Therapy in Rheumatoid Arthritis

NCT ID: NCT02030028

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2022-06-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACTHAR Gel

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

Group Type: OTHER

ACTHAR gel

Intervention Type: DRUG

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

Interventions

ACTHAR gel

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

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Dana Ascherman

OTHER

Sponsor Role: lead

Responsible Party

Dana Ascherman

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Larry W Moreland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY19050342

Identifier Type: -

Identifier Source: org_study_id