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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Gouty Arthritis

In brief

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.

Key facts

Study ID: NCT03002974
Run by: Swedish Orphan Biovitrum
People needed: 165
Starts: 2016-12-01
Expected to finish: 2019-08-01
Last updated by the study team: 2020-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Fundamental Research, LLC — Gulf Shores, Alabama, United States
Coastal Clinical Research, Inc — Mobile, Alabama, United States
Advanced Research Center — Anaheim, California, United States
Delta Waves Sleep Disorder and Research Center — Colorado Springs, Colorado, United States
Pulmonary Associates of Brandon — Brandon, Florida, United States
Meridien Research — Brooksville, Florida, United States
Health Awareness — Jupiter, Florida, United States
Well Pharma Medical Research — Miami, Florida, United States
Clinical Neuroscience Solutions — Orlando, Florida, United States
Clinical Research Trials of Florida — Tampa, Florida, United States
Meridien Research, Inc — Tampa, Florida, United States
Kaushik Amin MD — Conyers, Georgia, United States
Alta Pharmaceutical Research Center — Dunwoody, Georgia, United States
Lemah Creek Clinical Research — Melrose Park, Illinois, United States
The Research Group of Lexington — Lexington, Kentucky, United States
Clinical Trials Management — Metairie, Louisiana, United States
University of Michigan — Ann Arbor, Michigan, United States
Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
Duke University Medical Center — Durham, North Carolina, United States
Boiling Springs Medical Research, Inc. — Shelby, North Carolina, United States
PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
Hightop Medical Research Center — Cincinnati, Ohio, United States
New Horizons Clinical Research — Cincinnati, Ohio, United States
Clinical Research Solutions - Franklin — Franklin, Tennessee, United States

Full record on ClinicalTrials.gov

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