EUCTR2015-004292-69-BE进行中（未招募）1 期
Anakinra (Kineret®) for a hereditary autoinflammatory disease with MEFV mutation and inflammasome activation.
Z Leuven0 个研究点开始时间: 2015年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1.Adult patients with a hereditary autoinflammatory syndrome and S242R MEFV mutation, manifesting active disease both clinically (cutaneous and articular inflammation) and biologically (increased acute phase reactants).
- •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 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients with underlying active infectious disorder, and/or visceral organ involvement constituting a potential risk according to the investigator, will be excluded
- •2.Treatment with biological agents (esp. TNF antagonists) is not allowed during the trial, they will be stopped as follows:
- •Infliximab therapy will be stopped at least 8 weeks, and adalimumab/Etanercept will be stopped at least 4 weeks prior to baseline visit and first treatment with Anakinra
- •3.Treatment with classical DMARDS (esp. methotrexate and cyclosporine) is not allowed during the trial and will be stopped at least 4 weeks prior to baseline/first treatment with Anakinra
- •4.Corticosteroids are not allowed except for low-dose corticosteroids (<= 10mg prednisone equivalent daily) which can be kept stable during the trial.
- •5.Pregnant or breastfeeding women.
- •6.Participation in any clinical trial investigation within 4 weeks prior to dosing or longer if
- •required by local regulation.
- •7.Positive test for or prior history of HIV (ELISA and Western blot), Hepatitis B (Hepatitis B surface antigen) or Hepatitis C.
- •8.Presence of active infections or a history of pulmonary TB infection with or without
- •documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study.
- •9.Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines were allowed throughout the course of this study and up to 3 months following the last dose.
- •10.History of malignancy except for treated basal cell carcinoma
- •11.History of recurrent and/or evidence of active bacterial, fungal or viral infection(s).
- •12.Presence of any of the following laboratory abnormalities: ALT or AST greater than 2 times the upper limit of normal (ULN), platelet count less than 100x109/L.
- •13.Patients with neutropenia (absolute neutrophil count [ANC] < 1.5 x 109/l)
- •14.History of significant medical conditions, which in the investigator’s opinion would exclude the patient from participating in this trial.
研究者
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