Actively Recruiting
Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Led by Massachusetts General Hospital · Updated on 2026-01-20
150
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
ANI Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare. The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period. The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.
CONDITIONS
Official Title
Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in this study
- Male and female patients, aged 18-85 years
- Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
- Onset of current acute gout flare within 5 days prior to study entry
- Body mass index of less than or equal to 45 kg/m2
- Baseline pain intensity 50 mm on the 0-100 mm visual analog scale (VAS)
- History of 1 gout flares within the 12 months prior to study entry
- The patient meets at least one of the following criteria for both NSAIDs and colchicine treatment options:
- Minimum of one episode of being intolerant, or unresponsive to the treatment
- Investigator deems the patient contraindicated or inappropriate for the treatment
- Patients must be willing and capable of using an electronic device and have access to a cellphone to complete surveys
You will not qualify if you...
- Patients with scleroderma, osteoporosis, active or recurrent infections, ocular herpes simplex
- Recent surgery within 2 weeks prior to randomization or unhealed operation wounds
- History or presence of peptic ulcer, uncontrolled congestive heart failure, hypertension, or diabetes type 1 or 2
- Sensitivity to proteins derived from porcine sources
- Primary adrenocortical insufficiency or hyperfunction
- Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis
- Polyarticular gouty arthritis involving more than 4 joints
- Participation in another investigational study within 30 days or prior investigational drug use within five half-lives
- Previous inclusion in this study
- Severe renal impairment with creatinine clearance less than 30 mL/min/1.73m2
- Uncontrolled clinically significant hematologic, CNS, hepatic, pulmonary, gastrointestinal, metabolic, or endocrine disease
- Any medical or psychological condition or lab result posing risk or interfering with study compliance
- Prior or current treatment with any ACTH product
- Pregnant or nursing women; women of childbearing age must use acceptable contraception
- Patients on urate-lowering therapy must have stable dose and regimen for at least 2 weeks before and 1 week after treatment
- Use of specified pain relief medications or biologics within specified periods prior to randomization
- Vaccination within 30 days prior to study enrollment and during the study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Ana D Fernandes, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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