EUCTR2006-005455-15-DE进行中（未招募）不适用
A three-part multicenter study, with a randomized, doubleblind, placebo controlled, withdrawal design in Part II to assess efficacy, safety, and tolerability of ACZ885 (antiinterleukin-1ß monoclonal antibody) in patients with Muckle-Wells Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •From the complete list of the protocol:
- •Molecular diagnosis of NALP3 mutations and clinical picture resembling MWS.
- •Male and female patients aged 4 to 75 years at the time of the screening visit.
- •For patients under anakinra therapy or any other investigational IL-1 blocking therapy, willingness to discontinue the treatment.
- •Are the trial subjects under 18? yes
- •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
- •From the complete list of the protocol:
- •Use of the following therapies:
- •Etanercept in the 4 weeks prior to the baseline visit (Day 1)
- •Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
- •Infliximab in the 12 weeks prior to the baseline visit (Day 1)
- •Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1) (with the exception of anakinra therapy and IL-1 blocking therapies –see below)
- •Patients who are on IL-1 blocking biological therapies (including anakinra therapy) need to discontinue this treatment. As soon as the criteria for relapse are fulfilled, patients can enter the study and receive ACZ885 treatment. This run-in phase reduces the classical wash-out phase to a medically meaningful time and avoids unnecessary suffering for the patient in case a predefined wash-out period per protocol is too long for an individual subject.
- •Leflunomide in the 4 weeks prior to the baseline visit (Day 1)
- •Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
- •Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
- •i.v. immunoglobulin (i.v. Ig) in the 8 weeks prior to the baseline visit (Day 1)
- •6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
- •Colchicine, dapsone, mycophenolate mofetil in the 3 weeks prior to the baseline visit (Day 1)
- •Corticosteroids =20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
研究者
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