EUCTR2016-004505-13-DE进行中（未招募）1 期
Tocilizumab for the Treatment of Familial Mediterranean Fever – A randomized, doubleblind, phase II proof of concept study-TOFFIFE - Tocilizumab for the Treatment of Familial Mediterranean Fever
niversity Hospital Tuebingen0 个研究点目标入组 30 人开始时间: 2017年8月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •-Age = 18 years and written informed consent
- •-FMF according to the Tel Hashomer Criteria (Appendix); with at least one heterozygous or homozygous mutation of the MEFV gene
- •-Inadequate response or intolerance to colchicine
- •-Attack during the last 12 weeks, defined as episodes of fever and/or pericarditis and/or serositis and/or testis involvement and/or arthritis and/or erysipelas-like rash and
- •-CRP >0.5mg/dl and/or ESR >20mm/h and/or SAA >10mg/dl
- •-Physician Global Assessment (PGA) >2
- •-Able and willing to provide written informed consent and to comply with the study protocol
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •-Age < 18 years
- •-Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization
- •-Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
- •Exclusions Related to Prior or Concomitant Therapy
- •-Previous treatment with TCZ
- •-Treatment with glucocorticosteroide > 10mg/day within 1 week; prednisolone = 10mg/day can be given on a stable dose throughout the study
- •-Analgesic medication other than paracetamol or ibuprofen or diclofenac, which can be used at a stable dose and for treatment of FMF attacks.
- •-Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
- •-Treatment with Anakinra within the last 1 week prior to baseline (ptb), Canakinumab within the last 8 week prior to baseline
- •-Treatment with etanercept within 2 weeks; certolizumab pegol, abatacept or adalimumab within 6 weeks; golimumab and infliximab within 8 weeks ptb
- •-Rituximab within 24 weeks ptb
- •-Leflunomide within 12 weeks ptb (washout possible),
- •-azathioprine, cyclophosphamide within 12 weeks ptb
- •-Immunization with a live/attenuated vaccine within = 4 weeks ptb
- •-Previous treatment with cell-depleting therapies, including investigational agents or approved therapies: anti-CD33, anti-CD52, anti-CD4, anti-CD5, anti- CD3 and anti-CD19
- •-Treatment with intravenous gamma globulin within 6 months of baseline
- •-Treatment with plasmapheresis within 6 months of baseline
- •-Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- •Exclusions Related to General Safety
- •-History of severe allergic or anaphylactic reactions to human, humanized, or murine antibodies
- •-Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, psychiatric or GI disease
- •-History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
- •-Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- •-Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
- •-Active TB requiring treatment within the previous 3 years; Patients should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment; Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible.
- •-Primary or secondary immunodeficiency (history of or currently active)
- •-Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
- •-Females of childbearing potential who are not willing to use an effective method of contraception, such as condom, sterilization, or true abstinence throughout stu
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