ACTH Gel Therapy in Rheumatoid Arthritis

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Clinical Disease Activity Index
    • Time Frame: 12 weeks
    • We propose a 20% improvement after 12 weeks of therapy compared to baseline as a positive response.

Secondary Measures

  • Change in the Disease Activity Score
    • Time Frame: 12 weeks
    • We expect an improvement in the disease activity score along with an improved C-Reactive protein value.
  • Changes in acute phase reactants
    • Time Frame: 12 weeks
    • We expect the erythrocyte sedimentation rate (ESR) and the C-reactive protein value to improve.
  • Patient reported changes in fatigue
    • Time Frame: 12 weeks
    • We expect patient to report using the FACIT-F scoring tool to report improvement in their level of fatigue.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dana Ascherman
  • Collaborator
    • Mallinckrodt
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dana Ascherman, Professor – University of Pittsburgh
  • Overall Official(s)
    • Larry W Moreland, MD, Principal Investigator, University of Pittsburgh
  • Overall Contact(s)
    • Laurie Hope, RN, 412-647-2638, hopelk@upmc.edu

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