EUCTR2010-024172-26-PL进行中（未招募）不适用
A randomized, double-blind, double-dummy, active 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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Signed written informed consent before any study procedure is performed.
- •2. Male or female patients aged = 18 - = 85 years
- •3. Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of
- •primary gout.
- •4. Onset of current acute gout flare within 5 days prior to randomization.
- •5. Patient’s assessment of baseline pain intensity = 50 mm on the 0-100 mm VAS.
- •6. History of = 3 gout flares within the 12 months prior to randomization (based on patient history, referral letter and/ or patient interview).
- •7. Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for:
- •a. NSAIDs defined as (based on medical history, referral letter, and/ or patient
- •interview)and/or
- •b. colchicine (based on medical history, referral letter, and/ or patient interview)
- •8. 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.
- •9. BMI = 45 kg/m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1. Use of the following therapies:
- •a. Corticosteroids:
- •A dose of = 10mg of prednisolone or equivalent within 24 hours before screening
- •for any indication.
- •Chronic corticosteroid treatment (defined as a prednisolone dose of = 5 mg/ day
- •or equivalent taken for more than 28 days)
- •Intra-articular corticosteroids into the most affected joint within 14 days before
- •Intra-muscular corticosteroids for any indication within 14 days before screening.
- •b. Narcotics (opiates and tramadol) within 24 hours before screening
- •c. NSAIDs (including Cox-2 inhibitors) and other pain medication as defined below:
- •Any acetaminophen (paracetamol) within 4 hours before screening or > 1 g within 24 hours before screening
- •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
- •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
- •d. Colchicine: > 1.2 mg within 24 hours before screening
- •e. Topical ice/ cold packs within 6 hours before screening
- •f. Chronic opiate treatment within 14 days before screening
- •g. 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.
- •h. Herbal therapy treatment taken orally for gout indication one month before screening.
- •Topical herbal therapy packs 6 hours before screening.
- •i. Acupuncture treatment for gout indication one month before screening
- •2. Hemodialysis
- •3. Live vaccinations within 3 months prior to randomization.
- •4. Donation or loss of 400 mL or more of blood in the 8 weeks prior to randomization.
- •5. 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).
- •6. 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.
- •7. Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- •8. Secondary gout chemotherapy induced gout, lead induced gout and transplant gout.
- •9. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute
- •inflammatory arthritis.
- •10. 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).
- •11. Presence of idiopathic thrombocytopenic purpura.
- •12. Known presence or suspicion of Human Immunodeficiency Virus (HIV) infection,
- •Hepatitis B and Hepatitis C infectio
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