Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07346079
Phase
PHASE4
Status
Recruiting
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Conditions

  • Gout
  • Gout Arthritis
  • Gout Flare

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Purified Cortophin Gel, 40 U — DRUG
    This will be the 40 U dose of the purified Cortophin Gel
  • Purified Cortophin Gel 80 U — DRUG
    This will be the 80 U dose of the purified Cortophin Gel

Study Details

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.

Key Dates

Start date
Dec 20, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Purified Cortophin Gel 40 U
    Patients in this arm will receive the 40 U dose at Day 0
  • Experimental: Purified Cortophin Gel 80 U
    Patients in this arm will receive the 80 U dose at Day 0

Primary Outcome Measure

Change in gout pain intensity from baseline in target join to 72 hours post-injection [ Time Frame: From baseline to Day 3/Visit 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General HospitalBostonMassachusetts02114-

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By research site
Mass General Hospital· Boston, MA

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