Purified Cortrophin® Gel for treating acute gout flares at two dose levels

A Randomized, Multicenter, Double-blind, Efficacy and Safety Study of 2 Dose Levels of Purified Cortrophin® Gel in Patients With Acute Gouty Arthritis Flares

This study will try two single injections (40 U and 80 U) of Purified Cortrophin® Gel to see which dose better and more quickly reduces pain in adults having an acute gout flare.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07346079 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, multicenter study that compares a single subcutaneous or intramuscular injection of 40 U versus 80 U Purified Cortrophin® Gel in adults with acute gout flares. Patients are randomized 1:1 and followed with assessments at 24, 48, and 72 hours and again on Day 7 after dosing. Pain intensity and safety measures are collected at each visit to characterize short-term benefit and adverse effects. The study enrolls adults with recent-onset flares who are intolerant of or contraindicated for standard gout flare therapies such as NSAIDs or colchicine.

Who should consider this trial

Good fit: Adults aged 18–85 with a recent (within 5 days) acute gout flare, baseline pain ≥50 mm on a 0–100 mm VAS, a history of at least one gout flare in the past year, and who are intolerant of or inappropriate candidates for NSAIDs or colchicine are eligible.

Not a fit: Patients with mild flares, symptom onset beyond five days, BMI >45 kg/m2, or those who respond well to and can safely use standard therapies like NSAIDs or colchicine may not gain additional benefit from this treatment.

Why it matters

Potential benefit: If successful, a single-dose Cortrophin® injection could offer rapid pain and inflammation relief for gout flares, especially for patients who cannot take or do not tolerate standard therapies.

How similar studies have performed: Similar corticotropin/ACTH preparations have shown benefit in smaller studies and clinical use for gout flares, but large, high-quality randomized data remain limited.

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 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 Criteria:

* 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.

Where this trial is running

Boston, Massachusetts

• Mass General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Hyon K Choi, MD, DrPH — Massachusetts General Hospital
• Study coordinator: Ana D Fernandes, MA

Conditions Gout Arthritis; Gout Flare; Gout