Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ANI Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purified Cortophin Gel 40 U | Experimental | Patients in this arm will receive the 40 U dose at Day 0 |
|
| Purified Cortophin Gel 80 U | Experimental | Patients in this arm will receive the 80 U dose at Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified Cortophin Gel, 40 U | Drug | This will be the 40 U dose of the purified Cortophin Gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to Day 3/Visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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])
| 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). |
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana D Fernandes, MA | Contact | 617-643-2140 | adfernandes@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hyon K Choi, MD, DrPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
IPD will only be shared with the sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Purified Cortophin Gel 80 U | Drug | This will be the 80 U dose of the purified Cortophin Gel |
|
| 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. | 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. | 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). | 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). | 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. | 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])
Absent or Present o Physician assessment of target joint range of motion 0 - Normal
The above answers will be totaled - minimum value: 0, max: 12. Higher values indicate worse outcomes. | 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). | Day 3 (Visit 2) |
| Use of rescue medication (up to 72-hours post-injection). | Use of rescue medication (up to 72-hours post-injection). | From baseline to Day 3/Visit 2 |
| Safety assessment - AEs, SAEs | Notes presence, description, duration of an AE, and whether the AE is serious. | 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 | 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. | Day 1 and Day 3 |
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).
The answers across all three questions will be totaled, with higher scores indicating worse outcomes. Minimum value: 3, maximum value: 15 |
| From baseline to Day 3/Visit 2 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |