EUCTR2018-003753-13-FR进行中（未招募）1 期
Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •?Diagnosis of Takayasu disease according to the international criteria of the American College of Rheumatology (ACR) (appendix 1)
- •oAge at disease onset < 40 years
- •oClaudication of extremities
- •oDecreased brachial artery pulse (one or both arteries)
- •oBlood pressure difference of >10mm Hg between the arms
- •oBruit over subclavian arteries or aorta
- •?Active disease according to the international criteria of the National Institute of Health (NIH) (appendix 2)
- •New onset or worsening of at least two of the following four criteria
- •oSystemic features
- •oElevated erythrocyte sedimentation rate
- •oFeatures of vascular ischemia or inflammation
- •oTypical angiographic features
- •?Refractory/relapsing disease
- •oFailure of disease to respond to daily corticosteroids therapy (1mg/kg/day for > 1month), i.e. disease still active
- •oInability to taper corticosteroids below 10mg/day within 6 months
- •oInability to discontinue corticosteroids after 1 year of treatment
- •oRelapse of disease after gradual decrease of corticosteroids therapy
- •?Patients with one immunosuppressive agent (methotrexate, azathioprine, mercaptopurine or mycophenolate mofetil)
- •?Age of 18 years or older
- •?Weight 40 – 120 kg
- •?Medical follow-up in a university or general hospital in France
- •?Social insurance
- •?Willing and able to provide written informed consent
- •?Willing and able to comply with treatment and follow-up procedures required by the study protocol
- •?For female subjects of child-bearing age, a negative serum pregnancy test
- •?For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, or condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
- •?Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to enrollment with no evidence of active tuberculosis, active infection, or malignancy
- •?Tuberculosis assessment:
- •oActive Tuberculosis infection treatment achieved
- •oCompletion of at least 3 weeks treatment for Latent Tuberculosis infection
- •oNegative tuberculin skin test (TST) or interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test)
- •A potential subject with a positive TST or IGRA at inclusion is eligible if her/his chest X-ray does not show evidence suggestive of active tuberculosis infection and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary tuberculosis infection. These subjects with a latent tuberculosis infection who have not already received a prophylactic tuberculosis treatment must agree in advance to complete such a treatment course.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •?Active tuberculosis or untreated latent tuberculosis
- •?Evidence of active infection (includes chronic infection)
- •?Infection requiring treatment with antibiotics within 2 weeks prior to enrollment
- •?Infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen.
- •?Pregnancy or lactation
- •?Inability to comply with study guidelines
- •?Inability to provide informed consent
- •?Immunosuppressant type or dose modification within 30 days prior to enrollment
- •?Alcohol or drug abuse, that, in the investigator’s opinion, could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures
- •?Severe renal insufficiency (creatinine clairance <30mL/min/1,73m2)
- •?Hepatic dysfunction as shown by aspartate transaminase (AST) or alanine transaminase (ALT) levels >5-fold the upper limit of normal
- •?Heart failure = stage III / IV NYHA,
- •?History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
- •?History of multiple sclerosis and/or demyelinating disorder
- •?History of severe allergic or anaphylactic reactions to cyclophosphamide, interferon or infliximab and prednisone.
- •?History of immediate hypersensitivity reaction to iodinated and gadolinium-based contrast media
- •?Cytopenia: Hemoglobin < 8.5 g/dL, absolute neutrophil < 1.5 G/L, Platelet count < 80 G/L
- •?Any live (attenuated) vaccine fewer than 4 weeks before enrolment. Recombinant or killed virus vaccines fewer than 2 weeks before enrolment.
- •?Use of the following systemic treatments during the specified periods
- •a-Treatment with biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, anakinra, tocilizumab, etanercept, abatacept, ixekizumab, secukinumab, ustekinumab, alemtuzumab) within 6 months prior to enrollment
- •b-Past treatment with rituximab within the past 12 months, or past treatment with rituximab more than 12 months ago where the B lymphocytes count has not returned to normal at time of enrollment
- •c-Treatment with any systemic alkylating agents within 6 months prior to enrollment (e.g., cyclophosphamide, chlorambucil)
- •?History of hypersensitivity to infliximab, other murine proteins, or to any of the excipients
- •?Hypersensitivity to Tocilizumab or to any of the excipients
- •?Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
- •?Presence of any of the following disease processes:
- •oMicroscopic polyangiitis
研究者
相似试验
尚未招募
不适用
Multicenter, prospective, randomized study comparing motorized spiral enteroscopy with double balloon enteroscopyK63.8K92.2Other specified diseases of intestineGastrointestinal haemorrhage, unspecifiedDRKS00025890Medizinische Klinik 1 Universitätsmedizin Frankfurt32
已完成
不适用
A multicentre prospective randomised trial comparing angioplasty versus stenting for the management of iliac occlusionsCardiovascular diseases: Peripheral arterial diseaseCirculatory SystemPeripheral arterial diseaseISRCTN48145465HS R&D Regional Programme Register - Department of Health (UK)140
进行中（未招募）
Unknown
Reducing chronic breathlessness in adults by following a self-guided, internet-based supportive interventioAdults living with chronic breathlessness due to malignant and non-malignant diseasesRespiratoryISRCTN13121835King's College Hospital NHS Foundation Trust246
暂停
不适用
Can new computer software technology be used to help place the pacing lead on the left side of the heart in the most beneficial position when a participant has a cardiac resynchronisation therapy device (CRT-D) implant?Ischaemic cardiomyopathyCirculatory SystemISRCTN91522248Guy's and St Thomas's NHS Foundation Trust218
招募中
不适用
A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.JPRN-UMIN000006131Tokyo Metropolitan Children's Medical Center124