EUCTR2014-002500-24-DE进行中（未招募）1 期
Open-label, multicenter, dose-escalating phase II study to investigate the safety, tolerability, and early signs of efficacy of subcutaneous administrations of Tadekinig alfa (IL-18BP) in patients with Adult -onset Still’s Disease (AoSD) during 12 weeks - THERAPEUTIC USE OF TADEKINIG ALFA IN ADULT-ONSET STILL’S DISEASE
AB2 Bio Ltd.0 个研究点目标入组 20 人开始时间: 2014年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Patients aged 18 years and older, diagnosed as AoSD based on the presence of the Yamaguchi criteria with active disease, irrespective of the continuation of the permitted treatment mentioned below
- •Patients with active disease will be considered if they exhibit at least two of the Yamaguchi’s major criteria at the screening visit plus at least either fever or elevation of markers of inflammation (CRP = 10 mg/L).
- •Patients that have been exposed to NSAIDS, Prednisone (at least 5 mg/day) for = 1 month) and/or synthetic sDMARDs (methotrexate at a dose of at least 10mg/week) for = 3 months without response to treatment or with incomplete response to treatment
- •Women of childbearing potential with negative pregnancy test at screening, V3, V4, V5 and V6 and that agree to follow highly effective birth control recommendations during the study and until 1 month after the end of the treatment. Birth control methods that are considered as highly effective are either: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- •In each case of delayed menstrual period (over one month between menstruations, confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to women of child bearing potential with infrequent or irregular menstrual cycles.
- •As regards the duration of contraception after the study, taking into account the median half-life of Tadekinig alfa of almost 40h, 5 half-lives represent duration of 200 hours. In order to be on the safe side, a post-study contraception duration of 4 weeks is recommended
- •Patients can maintain treatment with stable doses of Non-Steroidal anti-inflammatory Drugs (NSAIDs), Prednisone (stable dose of Prednisone (of at least 5 mg/day), and sDMARDs during Tadekinig alfa treatment (methotrexate at a dose of at least 10mg/week). Specifically baseline levels of prednisone treatment can be maintained or tapered (due to patient improvement), any requirement for prednisone increase during treatment will be considered a treatment failure.
- •Ability to understand and willingness to sign a written informed consent
- •Previous treatments with biologicals are allowed if the following wash-out periods are respected: one week for anakinra, two weeks for etanercept, and 6 weeks for adalimumab, certolizumab, golimumab, tocilizumab, abatacept and 8 weeks for infliximab. Previous rituximab administration will require 6 months of washout and normal B-cell counts and previous treatment with canakinumab will require 6 months of washout.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Patients with a first episode of AoSD with less than one month of therapy with Prednisone or sDMARDs
- •Patients with active or chronic infections (i.e. Tuberculosis (TB), HIV, HBV & HCV)
- •Patients suffering from inherited immunodeficiency diseases
- •Patients suffering from immune-mediated inflammatory diseases, including autoimmune diseases such as RA, SLE, etc., or spondylarthropathies, or inflammatory bowel disease.
- •Patients with white blood cell counts below 2’500 cells/mm3
- •Patients with Neutrophils below 1’000 cells/mm3
- •Concomitantly treated with biologicals
- •Women of childbearing potential who are unwilling to use highly effective birth control methods (see definition in Inclusion criteria above) up to 1 month after the end of her participation in the study.
- •Inability to understand and unwilling to sign a written informed consent
- •Active Macrophage Activation Syndrome (MAS)
- •Any acute or chronic life-threatening disease: such as cancer, and irreversible organ failures of heart, liver, lung and kidney (creatinine not higher than 1.5 X upper limit of normal)
- •Patients having received adalimumab, certolizumab, golimumab, tocilizumab and abatacept within 6 weeks, infliximab within 8 weeks, canakinumab within 6 months, etanercept within 2 weeks, or anakinra 1 week prior to the start of Tadekinig alfa will not be enrolled into the study. Patients that have received rituximab within 6 months and/or have persistent low B-cell counts will not be eligible for enrolment.
- •Subject who cannot be expected to comply with the study procedures
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
- •Patients with no social security coverage
- •Patients with a history of severe hypersensitivity reactions
研究者
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