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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: ACTHAR gel

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ACTHAR Gel; Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.	Drug: ACTHAR gel; Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.; Other Names: Adrenocorticotropic hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12	percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12	Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement. Scale: 0-8.61 (lower scores indicate reduced disease activity)	12 weeks
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12	Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0))	12 weeks
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12	Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0)	12 weeks
Patient Reported Changes in Fatigue Between Week 0 and Week 12	The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.	12 weeks

Collaborators and Investigators

• Sponsor: Dana Ascherman
• Collaborators: Mallinckrodt
• Investigators: Principal Investigator: Larry W Moreland, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimated): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; ACTH gel
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: STUDY19050342