Clinical trial NCT02030028: ACTH Gel Therapy in Rheumatoid Arthritis
Official title: Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
ACTH gel
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2014-01-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
timeFrame: 12 weeks
measure: Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
timeFrame: 12 weeks
measure: Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
timeFrame: 12 weeks
measure: Patient Reported Changes in Fatigue Between Week 0 and Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Larry W Moreland, MD
role: PRINCIPAL_INVESTIGATOR
References: