Back to search results

Purified Cortrophin® Gel for Acute Gout Flares

This study is testing Purified Cortrophin® Gel at two different dose levels (40 U and 80 U) to see how well and how safely it treats sudden, painful attacks of gout (gout flares). You may be able to join if you are between 18 and 85 years old, have had a gout flare start within the last 5 days, and meet other health criteria. The main goal is to see how much your gout pain changes in the affected joint within 72 hours after receiving the injection. This is a double-blind study, meaning neither you nor your doctors will know which dose you receive. The study aims to enroll 150 participants.

Study design
This is a randomized, multicenter, double-blind study involving 150 participants. Participants will receive either a 40 U or 80 U dose of Purified Cortrophin® Gel.
What's involved
You would have one injection of Purified Cortrophin® Gel. Your pain will be checked at 24, 48, and 72 hours after the injection, and again on day 7.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 7 days after receiving the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07346079

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

Recruiting
PHASE4Ages 18–90InterventionalTreatment
Massachusetts General Hospital
~150 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Purified Cortophin Gel, 40 UPurified Cortophin Gel 80 U

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in gout pain intensity from baseline in target join to 72 hours post-injection
Measured over From baseline to Day 3/Visit 2

Conditions

Gout Arthritis
Gout Flare
Gout

Explore related trials

Gout

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Hyon K Choi, MD, DrPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Ana D Fernandes, MA
[email protected]
617-643-2140
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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, see Appendices 2-4.
The investigator deems the patient is either contraindicated or inappropriate for the treatment. Inappropriateness could be due to anticipated changes in patient status (i.e., such as worsening of comorbidities or use of concomitant medication), see Appendices 2-4.
Patients must be willing and capable of using an electronic device (e.g., cellphone) and must have access to a cellphone to be able to complete surveys.

Exclusion

Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2 weeks prior to randomization or have an unhealed operation wound(s)), history of or the presence of a peptic ulcer, uncontrolled congestive heart failure, uncontrolled hypertension, uncontrolled diabetes type 1 or 2, or sensitivity to proteins derived from porcine sources.
Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
Rheumatoid arthritis, evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
Polyarticular gouty arthritis involving more than 4 joints.
Participation in another concurrent investigational study within 30 days of randomization or has taken an investigational drug within five times the half-life of that investigational drug has passed.
Previous inclusion in this study.
Presence of severe renal function impairment: estimated creatinine clearance \<30 mL/min/1.73m2 (CKD stages 4 and 5).
Uncontrolled clinically significant hematologic, CNS, hepatic, pulmonary, gastrointestinal, metabolic, or endocrine disease as deemed by the investigator.
Presence of any medical or psychological condition or laboratory result that might create risk to the patients (or interfere with the patient's ability to comply with the protocol requirements, or to complete the study) in the opinion of the investigator.
Prior or current treatment with any ACTH product.
Pregnant or nursing (lactating) women. Women of childbearing age are required to be using an acceptable method of contraception.
Patients taking urate-lowering therapy had to be on a stable dose and regimen for ≥2 weeks before entering the study and remain on a stable dosage and regimen for at least 1 week after Purified Cortrophin® Gel.
Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor \[TNF\] inhibitors) within specified periods (see Appendix 5) prior to randomization.
Vaccination within 30 days prior to study enrollment and during the study period.

What this trial measures

  • Change in gout pain intensity from baseline in target join to 72 hours post-injectionFrom baseline to Day 3/Visit 2

    Change in gout pain intensity from baseline in the target joint following PCG administration measured by Visual Analog Scale (VAS) at 72 hours post-injection (Day 3; Visit 2). Patients will score their pain intensity in the joint most affected at baseline (i.e., the index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100).