ACTH Gel Therapy in Rheumatoid Arthritis

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12	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 Outcome Measures

Name	Time	Method
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12	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))
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12	12 weeks	Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS \< 0)
Patient Reported Changes in Fatigue Between Week 0 and Week 12	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.
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12	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)

Locations (1): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States