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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Purified Cortophin Gel, 40 U
  This will be the 40 U dose of the purified Cortophin Gel
• Препарат Purified Cortophin Gel 80 U
  This will be the 80 U dose of the purified Cortophin Gel

Первичные конечные точки

• Change in gout pain intensity from baseline in target join to 72 hours post-injection [Срок оценки: From baseline to Day 3/Visit 2]

Вторичные конечные точки (12)

• Change in gout pain from baseline in target joint at Day 1 [Срок оценки: From baseline to Day 1]
• Change in gout pain intensity from baseline in target joint to Day 2 [Срок оценки: From baseline to Day 2]
• Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection. [Срок оценки: From baseline to Day 7]
• Time to onset of effect (≥20% change from baseline pain intensity on VAS). [Срок оценки: From baseline to end of study (Day 7)]
• Time to response (≥50% change from baseline pain intensity on VAS). [Срок оценки: 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). [Срок оценки: From baseline to end of study (Day 7)]
• Physician assessment of inflammatory signs: (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2]) [Срок оценки: From baseline to end of study (Day 7)]
• Physician assessment of local tolerability at injection site (at 72 hours post-injection). [Срок оценки: Day 3 (Visit 2)]
• Use of rescue medication (up to 72-hours post-injection). [Срок оценки: From baseline to Day 3/Visit 2]
• Safety assessment - AEs, SAEs [Срок оценки: From baseline to end of study (Day 7)]
• Safety Assessment - Vital Signs [Срок оценки: Day 1 Visit and Day 3 Visit]
• Safety Assessment - Laboratory Measurements [Срок оценки: Day 1 and Day 3]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mass General Hospital — Boston

Идентификаторы

NCT: NCT07346079 · 2025P001469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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