Gout ArthritisPhase 4NCT07346079
Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
A Phase 4 study testing Purified Cortophin Gel, 40 U and Purified Cortophin Gel 80 U in people with Gout Arthritis and Gout Flare, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gout Arthritis, Gout Flare, Gout
- What is being tested?
- Purified Cortophin Gel, 40 U and Purified Cortophin Gel 80 U
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2025to 31 Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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 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.
- Conditions
- Gout Arthritis, Gout Flare, Gout
- Being tested
- Purified Cortophin Gel, 40 U, Purified Cortophin Gel 80 U
- Medical subject headings
- Arthritis, Gouty, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified Cortophin Gel, 40 UDrug
This will be the 40 U dose of the purified Cortophin Gel
Purified Cortophin Gel 80 UDrug
This will be the 80 U dose of the purified Cortophin Gel
| Study group | Role | What they receive |
|---|---|---|
| Purified Cortophin Gel 40 U | Experimental | Patients in this arm will receive the 40 U dose at Day 0 Receives: Drug: Purified Cortophin Gel, 40 U |
| Purified Cortophin Gel 80 U | Experimental | Patients in this arm will receive the 80 U dose at Day 0 Receives: Drug: Purified Cortophin Gel 80 U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gout pain intensity from baseline in target join to 72 hours post-injection
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).
Measured: From baseline to Day 3/Visit 2
Secondary outcomes (12)
Change in gout pain from baseline in target joint at Day 1
Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration measured by Visual Analog Scale (VAS) at Day 1 (24 hours post-injection).
Minimum value: 0 Maximum value: 10
Higher score indicates worse outcome.
Measured: From baseline to Day 1
Change in gout pain intensity from baseline in target joint to Day 2
Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration as measured by Visual Analog Scale (VAS) at Day 2 (48 hours post-injection).
Minimum value: 0
Maximum value: 10
Higher score indicates worse outcome.
Measured: From baseline to Day 2
Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.
Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.
Measured: From baseline to Day 7
Time to onset of effect (≥20% change from baseline pain intensity on VAS).
Time to onset of effect (≥20% change from baseline pain intensity on VAS).
Measured: From baseline to end of study (Day 7)
Time to response (≥50% change from baseline pain intensity on VAS).
Time to response (≥50% change from baseline pain intensity on VAS).
Measured: From baseline to end of study (Day 7)
Patient Global Self-Assessment to treatment: (24 hours, 48 hours, 72 hours, and Day 7 post-injection).
Patient Global Self-Assessment to treatment: (24 hours, 48 hours, 72 hours, and Day 7 post-injection).
4 - Excellent 3 - Good 2 - Acceptable
1 - Slight 0 - Poor
Lower scores indicate worse outcomes.
Measured: From baseline to end of study (Day 7)
Physician assessment of inflammatory signs: (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])
Physician assessment of inflammatory signs: (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])
- Physician assessment of joint tenderness 0 - No pain
- - Mild/patient there is pain when touched
- - Moderate/patient states there is pain and winces
- - Severe/patient states there is pain, winces and withdraws.
- Physician assessment of joint swelling 0 - No swelling
- - Mild swelling/palpable
- - Moderate swelling/visible
- - Severe swelling/bulging beyond the joint margins
- Physician assessment of erythema
Absent or Present
- Physician assessment of target joint range of motion
0 - Normal
- - Mildly restricted
- - Moderately restricted
- - Severely restricted
- - Immobilized
The above answers will be totaled - minimum value: 0, max: 12. Higher values indicate worse outcomes.
Measured: From baseline to end of study (Day 7)
Physician assessment of local tolerability at injection site (at 72 hours post-injection).
Physician assessment of local tolerability at injection site (at 72 hours post-injection)
Notes presence of redness, swelling, pain, bruising, itching (no numerical values).
Measured: Day 3 (Visit 2)
Use of rescue medication (up to 72-hours post-injection).
Use of rescue medication (up to 72-hours post-injection).
Measured: From baseline to Day 3/Visit 2
Safety assessment - AEs, SAEs
Notes presence, description, duration of an AE, and whether the AE is serious.
Measured: From baseline to end of study (Day 7)
Safety Assessment - Vital Signs
Height and Weight will be collected, and used to calculate the participant's BMI
Measured: Day 1 Visit and Day 3 Visit
Safety Assessment - Laboratory Measurements
Biochemistry:
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Total bilirubin (if >upper limit of normal also conjugated and non-conjugated bilirubin) Alkaline phosphatase (ALP） Prothrombin Time/International Normalized Ratio (PT/INR)‡¥§ Albumin Cholesterol (total, LDL, and HDL) Triglycerides Creatinine◊§ Sodium (Na) Potassium (K) Ferritin Erythrocyte sedimentation rate Uric acid Glucose*¥ HbA1c Troponin T C-reactive protein (CRP) Serum amyloid A (SAA) Calcium Magnesium
Hematology:
Hemoglobin Hematocrit White blood cells Differential blood count Thrombocytes
Urine analysis:
Albumin U-erythrocytes
Abnormal test findings, if changed significantly from baseline will be noted. Minimum and maximum values, as well as indications of higher or lower values vary depending on the test.
Measured: Day 1 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Dec 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ANI Pharmaceuticals
- Responsible party
- Principal investigator, Hyon Choi, Massachusetts General Hospital
- Investigators
- Hyon K Choi, MD, DrPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346079
- Sponsor's protocol ID
- 2025P001469
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared with the sponsor.