Clareo Health | Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Core Study:
Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
Onset of current acute gout flare within 5 days prior to study entry
Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
History of ≥ 3 gout flares within the 12 months prior to study entry
Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine
Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).
You may not be if
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
Presence of severe renal function impairment
Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry
Live vaccinations within 3 months prior to randomization
Requirement for administration of antibiotics against latent tuberculosis (TB)
Refractory heart failure (Stage D)
Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion:
\- Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.
Exclusion:
\- Continuation in this extension study was considered inappropriate by the treating physician.
Extension Study 2:
Continuation in this second extension study was considered inappropriate by the treating physician.
