A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis (anaGO)
Acute Gouty Arthritis
About this trial
This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Fundamental Research, LLC
- Coastal Clinical Research, Inc
- Advanced Research Center
- Delta Waves Sleep Disorder and Research Center
- Pulmonary Associates of Brandon
- Meridien Research
- Health Awareness
- Well Pharma Medical Research
- Clinical Neuroscience Solutions
- Clinical Research Trials of Florida
- Meridien Research, Inc
- Kaushik Amin MD
- Alta Pharmaceutical Research Center
- Lemah Creek Clinical Research
- The Research Group of Lexington
- Clinical Trials Management
- University of Michigan
- Albuquerque Clinical Trials
- Duke University Medical Center
- Boiling Springs Medical Research, Inc.
- PMG Research of Winston-Salem
- Hightop Medical Research Center
- New Horizons Clinical Research
- Clinical Research Solutions - Franklin
- Clinical Research Solutions
- Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC
- Pioneer Research Solutions, Inc.
- Accurate Clinical Management
- Sun Research Institute
- Wade Family Medicine
- Ericksen Research & Development
- Advanced Clinical Research - West Jordan
- Commonwealth Clinical Research Specialists, Inc.
- Corporation Lane Internal Medicine and Research Center
- Mileground Physicians, PLLC
- Clinical Investigations Specialists, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Anakinra 100 mg
Anakinra 200 mg
Triamcinolone 40 mg
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg
2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg