Purified Cortrophin® Gel for Gout Flare Treatment

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

Recruiting Phase 4 Interventional Study
Gout Arthritis Gout Flare Gout
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for

This trial is looking for adults with acute gout flares who want to test a treatment called Purified Cortrophin® Gel. Participants will receive one dose of the gel and follow up for a week to see how it works.

Are You a Good Fit for This Trial?
Rules you out SclerodermaSevere kidney impairmentRheumatoid arthritisUncontrolled diabetes

You may be able to join if

  • I am between 18 and 85 years old.
  • I have been diagnosed with gout.
  • I have had a gout flare within the last 5 days.
  • My pain level is 50 mm or higher on a 0-100 scale.
  • I have had at least 1 gout flare in the last year.
  • I cannot tolerate or respond to NSAIDs or colchicine.
  • I can use a cellphone to complete surveys.
  • I have signed consent to participate.

You may not be able to join if

  • I have a history of scleroderma or active infections.
  • I have uncontrolled heart failure or high blood pressure.
  • I have a severe kidney problem.
  • I have rheumatoid arthritis or other major joint issues.
  • I participated in another study in the last 30 days.
  • I am pregnant or nursing.
  • I have taken certain pain medications recently.
  • I have had recent surgery or open wounds.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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 p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 …
Contacts

Ana D Fernandes, MA

617-643-2140

adfernandes@mgh.harvard.edu

CONTACT