Purified Cortrophin Gel for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Hyon K Choi, MD, DrPH
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 with acute gout flares, meeting specific gout criteria, and who've had a flare within the last 5 days. They must have experienced at least one flare in the past year and be intolerant or unresponsive to standard treatments. Participants need a BMI ≤45 kg/m^2, significant pain, and must use an electronic device for surveys.Inclusion Criteria
Timeline for a Trial Participant
Pre-screening
Optional pre-screening period to determine initial eligibility
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of Purified Cortrophin® Gel (40 U or 80 U) and are monitored for efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Purified Cortrophin® Gel
Trial Overview
The study tests two doses of Purified Cortrophin® Gel (40 U and 80 U) on patients with acute gouty arthritis. It's randomized and double-blind; participants receive a single dose subcutaneously or intramuscularly and are monitored over seven days to assess efficacy and safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients in this arm will receive the 80 U dose at Day 0
Patients in this arm will receive the 40 U dose at Day 0
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
ANI Pharmaceuticals
Industry Sponsor
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