A Phase 4 interventional study of Purified Cortophin Gel, 40 U and Purified Cortophin Gel 80 U in Gout Arthritis, Gout Flare and Gout, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
Among 15 studies in Arthritis, Gouty with a site in United States — 3 open to participants now, 4 under way, 1 of them phase 3. Arthritis, Gouty · United States.
Among the 15 studies in Arthritis, Gouty with a site in United States, this one is the 8th largest by planned enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2025, is the only one in phase 4, and was the 15th registered.
47 studies on the registry are indexed under Arthritis, Gouty; 16 are open to participants now.
Browse Arthritis, Gouty studies →3 of the 15 studies in Arthritis, Gouty with a site in United States are open now. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Olatec Therapeutics, Inc. · Sites in United States, France, Israel and 2 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Arthritis, Gouty studies recruiting now, 8 (89%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 6 · Phase 4 1
First in 2008; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 150 is close to the median of 140 across 35 interventional studies indexed under Arthritis, Gouty.
Median enrollment 225 across the 14 interventional studies, 843 across the 1 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
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13 of 15 have an industry lead sponsor. The 9 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Massachusetts General Hospital has 1 study filed under Arthritis, Gouty — fewer than ten, so there is no comparison to draw.
3 of the studies in Arthritis, Gouty with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05658575Phase 3Olatec Therapeutics, Inc.Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare | 2026-12-31 |
| NCT07116746Arthrosi TherapeuticsEvaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients | 2026-11 |
| NCT07346079Massachusetts General HospitalPurified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares | 2027-08-31 |
Among the 15 studies in Arthritis, Gouty with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of specified pain relief medications or biologics (including , narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor [TNF] inhibitors) within specified periods (see Appendix 5) prior to randomization.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will receive the 40 U dose at Day 0
Drug: Purified Cortophin Gel, 40 U
Patients in this arm will receive the 80 U dose at Day 0
Drug: Purified Cortophin Gel 80 U
This will be the 40 U dose of the purified Cortophin Gel
This will be the 80 U dose of the purified Cortophin Gel
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).
Time frame: From baseline to Day 3/Visit 2
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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 1. \- Mild/patient there is pain when touched 2. \- Moderate/patient states there is pain and winces 3. \- Severe/patient states there is pain, winces and withdraws. * Physician assessment of joint swelling 0 - No swelling 1. \- Mild swelling/palpable 2. \- Moderate swelling/visible 3. \- Severe swelling/bulging beyond the joint margins * Physician assessment of erythema Absent or Present o Physician assessment of target joint range of motion 0 - Normal 1. \- Mildly restricted 2. \- Moderately restricted 3. \- Severely restricted 4. \- Immobilized The above answers will be totaled - minimum value: 0, max: 12. Higher values indicate worse outcomes.
Time frame: 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).
Time frame: Day 3 (Visit 2)
Use of rescue medication (up to 72-hours post-injection).
Use of rescue medication (up to 72-hours post-injection).
Time frame: From baseline to Day 3/Visit 2
Safety assessment - AEs, SAEs
Notes presence, description, duration of an AE, and whether the AE is serious.
Time frame: 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
Time frame: 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.
Time frame: Day 1 and Day 3
Levels of inflammatory markers (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])
Levels of inflammatory markers (baseline \[Day 0; Visit 1\], 72 hours \[Day 3; Visit 2\]) * C-reactive protein * Serum amyloid A
Time frame: From baseline to Day 3/Visit 2
Change from baseline in health-related quality-of-life Gout Attack Intensity Score (GAIS) at Day 0 (Visit 1) and at Day 3 (72-hours post-injection; Visit 2) (19).
Change from baseline in health-related quality-of-life Gout Attack Intensity Score (GAIS) at Day 0 (Visit 1) and at Day 3 (72-hours post-injection; Visit 2) (19). 1. How much pain is your gout causing you today? (color in one box completely) * 1 No pain * 2 Mild pain * 3 Moderate pain * 4 A lot of pain * 5 Extreme pain 2. How tender to the touch are the gout-affected parts of your body today? (colour in one box completely) * 1 Not tender * 2 Slightly tender * 3 Fairly tender * 4 Very tender * 5 Extremely tender 3. How swollen are the gout-affected parts of your body today? (colour in one box completely) * 1 Not swollen * 2 Somewhat swollen * 3 Fairly swollen * 4 Very swollen * 5 Extremely swollen The answers across all three questions will be totaled, with higher scores indicating worse outcomes. Minimum value: 3, maximum value: 15
Time frame: From baseline to Day 3/Visit 2
Plan to share: No — IPD will only be shared with the sponsor.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Aug 2027, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
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