Skip to main content
OpenTrials
Completed

NCT Number: NCT02030028

ACTH Gel Therapy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acthar Gel

Drug

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

Other names: Adrenocorticotropic hormone

Primary outcomes

  1. Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12

    Time frame: 12 weeks

    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)

Secondary outcomes

  1. Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12

    Time frame: 12 weeks

    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)

  2. Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12

    Time frame: 12 weeks

    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))

  3. Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12

    Time frame: 12 weeks

    Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0)

  4. Patient Reported Changes in Fatigue Between Week 0 and Week 12

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Dana Ascherman

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2014
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.