ACTH Gel Therapy in Rheumatoid Arthritis

NCT02030028 | Completed Results

• 1 other identifier: STUDY19050342
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; ACTH gel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  12 weeks

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

  12 weeks

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

  12 weeks

• Patient Reported Changes in Fatigue Between Week 0 and Week 12

  12 weeks

Study Arms (1)

ACTHAR Gel

OTHER

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

Drug: ACTHAR gel

Interventions

ACTHAR gel DRUG

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

Also known as: Adrenocorticotropic hormone

ACTHAR Gel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana Ascherman: lead
• Mallinckrodt: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

This trial was limited by small sample size and reduced number of participants completing the study. Statistical analysis was compromised by missing standard-of-care laboratory values.

Results Point of Contact

• Title: Dr. Dana Ascherman (Principal Investigator)
• Organization: University of Pittsburgh

DAscher@pitt.edu

14123838123

Study Officials

• Larry W Moreland, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: November 1, 2014
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2023-08

Locations

US (1)