EUCTR2010-020061-24-IE进行中（未招募）不适用
An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long-term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203
适应症
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
- 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
- •1. Patient’s written informed consent for = 18 years of age before any assessment is performed. Parent or legal guardian’s written informed consent and child’s assent, if appropriate, are required before any assessment is performed for patients < 18 years of age.
- •2. Male and female patients at least 4 years of age at the time of the screening visit.
- •3. Patients with a clinical diagnosis of TRAPS and a mutation of TNFRSF1A gene. Patients with low penetrance mutations, such as R92Q or P46L, can be included with mutual agreement between the investigator and Novartis.
- •4. Patients with a diagnosis of recurrent TRAPS must experience more than 6 episodes/year prior to receiving an effective biologic therapy and the duration of each episode lasted at least 8 days. For patients receiving biologic therapy, this criterion applies to prior to receiving the biologic therapy.
- •5. Patients who have been treated with anakinra must have demonstrated a partial or complete clinical response with an associated decrease in their inflammation markers (CRP and SAA).
- •6. Active TRAPS as evidenced by clinical signs and symptoms of active TRAPS (Physician’s Global Assessment = 2) and an elevated CRP > 10mg/L (Normal CRP range = 10 mg/L) and/or SAA > 10 mg/L (Normal SAA range = 10 mg/L) at time of first canakinumab treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •2. Women of child-bearing potential, defined as pre-menarche females aged 8 years and above or all women physiologically capable of becoming pregnant, UNLESS they are
- •women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- •women whose partners have been sterilized by vasectomy or other means
- •using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] is not acceptable) or total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance.
- •Women of child-bearing potential should be willing to use a reliable contraception
- •throughout the study and for 3 months after study drug discontinuation.
- •Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •3. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
- •4. Positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (= 5 mm induration) at screening or within 2 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (= 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test.
- •5. Live vaccinations within 3 months prior to the start of the trial, during the trial, and up months following the last dose.
- •6. History of significant other medical conditions, which in the Investigator’s opinion would exclude the patient from participating in this trial.
- •7. History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s).
- •8. Use of the following therapies:
- •a. Corticosteroids (oral prednisone (or equivalent)) > 0.2 mg/kg/day (or greater than the maximum of 15 mg/day for children over 60 kg) within 1 week prior to the Baseline visit
- •b. Anakinra within 24 hours prior to Baseline visit
- •c. Canakinumab within 3 months prior to Baseline visit
- •d. Rilonacept within 1 week prior to Baseline visit
- •e. Tocilizumab within 3 weeks prior to Baseline visit
- •f. Etanercept within 4 weeks prior to Baseline visit
- •g. Rituximab within 26 weeks prior to the Baseline visit
- •h. Leflunomide within 4 weeks prior to the Baseline visit. Documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required.
- •i. Thalidomide within 4 weeks prior to the Baseline visit
- •j. Cyclosporine within 4 weeks prior t
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