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ACTH Gel Therapy in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02030028
Recruitment Status : Recruiting
First Posted : January 8, 2014
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Dr. Larry W. Moreland, 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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ACTHAR gel Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Adrenocorticotropic hormone




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Changes in acute phase reactants [ Time Frame: 12 weeks ]
    We expect the erythrocyte sedimentation rate (ESR) and the C-reactive protein value to improve.

  3. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030028


Contacts
Contact: Laurie Hope, RN 412-647-2638 hopelk@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Laurie Hope, RN    412-647-2638    hopelk@upmc.edu   
Principal Investigator: Larry W Moreland, MD         
Sponsors and Collaborators
Dr. Larry W. Moreland
Mallinckrodt
Investigators
Principal Investigator: Larry W Moreland, MD University of Pittsburgh

Responsible Party: Dr. Larry W. Moreland, Margaret J. Miller Endowed Professor of Arthritis Research, Professor of Medicine, Immunology, and Clinical and Translational Science; Chief, Division of Rheumatology and Clinical Immunology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02030028     History of Changes
Other Study ID Numbers: PRO13080577
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: June 2018

Keywords provided by Dr. Larry W. Moreland, University of Pittsburgh:
Rheumatoid Arthritis
ACTH gel

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action