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

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.