A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective (CACZ885H2357)
- Conditions
- Gout10023213
- Registration Number
- NL-OMON35054
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
• Male or female patients aged >= 18 - <= 85 years
• Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of primary Gout.
• Onset of current acute gout flare within 5 days prior to randomization.
• Patient*s assessment of baseline pain intensity >= 50 mm on the 0-100 mm VAS.
• History of >= 3 gout flares within the 12 months prior to randomization (based on patient history, referral letter and/ or patient interview).
• Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for:
- NSAIDs (based on medical history, referral letter, and/ or patient interview) as defined in Appendix 9
and/or
- colchicine (based on medical history, referral letter, and/ or patient interview) as defined in Appendix 10.
• If on urate lowering therapy (e.g. allopurinol, febuxostat, pegloticase, probenecid) and/or on prophylactic low-dose colchicine, stable dose and schedule with no changes in therapy for 2 weeks prior to randomization and expected to remain on a stable regimen during study participation.
• BMI <= 45 kg/m2.
• Use of the following therapies:
- Corticosteroids:
o A dose of >= 10mg of prednisolone or equivalent within 24 hours prior to randomization for any indication.
o Chronic corticosteroid treatment (defined as a prednisolone dose of >= 5 mg/ day or equivalent).
o Intra-articular corticosteroids into the target joint within 14 days prior to randomization.
o Intra-muscular corticosteroids for any indication within 14 days prior to randomization.
- Narcotics (opiates and tramadol) within 24 hours prior to randomization
- Acetaminophen/ paracetamol within 4 hours prior to randomization
- Ibuprofen: any ibuprofen within 4 hours before screening (Day 1) or 400 mg within 8 hours before screening (i.e. 0-400 mg ibuprofen allowed between 4-8 hours before screening)
- Aspirin: any aspirin within 4 hours before screening or 600 mg within 24 hours before screening
- Over-the-counter analgesic aspirin-based or paracetamol-based combination medications: any number of tablets within 4 hours before screening or 2 tablets within 24 hours before screening
- Diclofenac: any diclofenac within 8 hours before screening or 50 mg within 24 hours before screening
- h. Naproxen: any naproxen within 12 hours before screening or 500 mg within 24 hours before screening
- Cox-2 inhibitors within 48 hours before screening
- Other NSAIDs within 24 hours before screening
- Colchicine: > 1.2 mg within 24 before screening
- Topical ice/ cold packs within 6 hours prior to randomization
- Chronic opiate treatment within 14 days prior to randomization
- Any IL-1 blocker, TNF inhibitor, other biologic or investigational drug within 30 days or 5 half-lives before randomization, whichever is longer, or as instructed by local regulations.
• Hemodialysis.
• Live vaccinations within 3 months prior to randomization.
• Donation or loss of 400 mL or more of blood in the 8 weeks prior to randomization.
• Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide (courses of antibiotic therapy started prior to entering the study should not be prematurely terminated to allow inclusion into the study).
• Refractory heart failure (Stage D). Patients for whom electrical device therapy is indicated (e.g. history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing ventricular tachycardia, with LVEF <35%) are excluded from the study. Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
• Secondary gout (e.g. chemotherapy induced gout, lead induced gout, transplant gout, etc.)
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• History of hypersensitivity to the study drugs or to molecules with similar structures, or contraindication to intramuscular injection (e.g. patients on anticoagulants, thrombocytopenia,
• known hemostasis disease).
• Presence of idiopathic thrombocytopenic purpura.
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment, where an IL-1 blocker might have an impact on underlying severe immunocompromising diseases as e.g. evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and/or clinical findings).
• One of the risk factors for TB such as but not limited or exclusive to:
- History o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pain (VAS 0-100) and occurence of new flare.</p><br>
- Secondary Outcome Measures
Name Time Method <p>% patients with at least 1 flare, pain intensity, pain at joint examination,<br /><br>global response to treatment, no pain, use of pain killers, physical inability,<br /><br>biomarkers, PK.</p><br>