A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The patients will be divided in different treatment groups to compare anakinra to the available drug triamcinolone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Interleukin 1 Receptor Antagonist Protein; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Signed Informed consent

• Patient meeting the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2015 gout classification criteria

• History of ≥1 self-reported flares of gouty arthritis within 12 months

• Current ongoing flare of gouty arthritis characterized by pain intensity

• Currently tender and swollen joint

• Onset of current flare within 4 days

• Intolerant, unresponsive, contraindicated or not appropriate for treatment with NSAIDs and colchicine (both treatment options)

• If on urate-lowering therapy, on a stable dose and regimen

• Women of childbearing potential willing to use adequate contraception

Inclusion criteria for treatment of subsequent flare(s)

• Current flare of gouty arthritis characterized by pain intensity

• Currently tender and swollen joint

• Women of childbearing potential willing to use adequate contraception

Exclusion Criteria:

• Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor inhibitors) within specified periods prior to randomization

• Contraindication to triamcinolone

• Polyarticular gouty arthritis involving more than 4 joints

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

• History of malignancy within the past 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy.

• Known hypersensitivity to Escherichia coli-derived proteins, Kineret® (anakinra), Kenalog® (triamcinolone acetonide) or any components of the products.

• Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection

• Presence of severe renal function impairment chronic kidney disease (CKD) stages 4 and 5

• Presence of neutropenia

• Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system or hepatic disease

• History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, New York Heart Association (NYHA) class III or IV heart failure within the previous 3 months

• Patients who have undergone major surgery within 2 weeks, or have an unhealed operation wound/s

• Presence of any medical or psychological condition or laboratory result that in the opinion of the investigator might create risk to the patients or to the study.

• Earlier or current treatment with anakinra

• Pregnant or lactating women

• History of >12 flares overall in the 6 months prior to randomization

Exclusion criteria for treatment of subsequent flare(s):

• Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection.

• Presence of severe renal function impairment CKD stages 4 and 5

• Presence of neutropenia

• History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, NYHA class III or IV heart failure within the previous 3 months

• Patients who have undergone major surgery within 2 weeks or have an unhealed operation wound/s.

• Pregnant or lactating women.

• Presence of any condition or laboratory result that in the opinion of the investigator makes the patient not appropriate for treatment