EUCTR2017-000845-39-IT进行中（未招募）1 期
THE ROLE OF ANTI TNF ALPHA AGENTS IN BEH¿ET¿S DISEASE REFRACTORY TO STANDARD OF CARE THERAPIES: MULTICENTER RANDOMIZED CONTROLLED PROSPECTIVE PARALLEL GROUP SINGLE-BLIND TRIAL TO EVALUATE THE 6 MONTH EFFECTIVENESS OF EITHER INFLIXIMAB OR ADALIMUMAB - FARM12LTAT
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
- 46
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
- •- Subject’s written informed consent given before any study-related procedure not part of the subject’s
- •normal medical care, with the understanding that consent may be withdrawn by the subject at any time
- •without prejudice to his or her future medical care;
- •-Age >=18-<65 years;
- •-Males or females;
- •-Diagnosis of BD according to the 1990 ISG criteria;
- •-Presenting active ocular and/or neurologic and/or muco-cutaneous manifestations, that have been occurred while on IS SoC therapy with either Aza or CsA of at least 3-month duration prior to study entry;
- •-Records’ availability for Aza or CsA and other IS SoC treatments (at least 3-month immunosuppressive standard of care therapy with azathioprine or cyclosporine A);
- •-Patients who develop severe and life-threatening complications treated with IS SoC and/or CS therapies;
- •- Concerning tubercolosis (TB), patients who meet no evidence of active or latent TB could be enrolled in the study. At screening, in case of a negative Quantiferon, TB Gold in Tube Test should be performed. Moreover a chest radiograph taken at screening or within the 3 months prior to the screening without evidence of active or latent TB infection should be registered.
- •Patients previously treated for TB could be enrolled in the study. The subjects should be included if they have previously received an adequate course of therapy as per local standard of care for either latent TB (9 months of isoniazid in a location where rates of primary multi drug resistant TB infections are <5% or an acceptable alternative regimen) or active TB. In these patients TB Gold in Tube Test (or equivalent assay) need be obtained. A chest radiograph must be obtained if not done so within 3 months prior to screening;
- •-Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent follow-up (see section 4.3).
- •Section 4.3 Contraceptive methods
- •In accordance with the CTFG recommendations related to contraception and pregnancy testing in clinical trials, birth control methods which may be considered as highly effective include the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal or Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable o Intrauterine device (IUD) o Intrauterine hormone-releasing system (IUS) o Bilateral tubal occlusion o Vasectomised partner(s).
- •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 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Actual end-stage” BD, with severe retinal damage or central nervous system (CNS) irreversible damage;
- •-Visual acuity < 1/10 on Snellen chart in both eyes or bilateral permanent blindness;
- •-Other severe BD manifestations, i.e. arterial aneurysm, thrombosis of the caval, hepatic veins, or cerebral sinuses;
- •-Any infection at screening or frequent acute or chronic infections within 3 months prior to the study entry;
- •-Congestive heart failure;
- •-Multiple sclerosis or any other central demyelinating disorder;
- •-History of malignancy within previous 5 years (except curatively excised skin cancer);
- •-Transplanted organ (except cornea);
- •-Substance abuse within 3 years;
- •-Enrollment in other investigative clinical trial;
- •-Prior history of anti TNF alpha agents’ or other monoclonal antibody treatments, or known allergy to murine or chimeric proteins
- •- Hypersensitivity to the active substances or to any of the excipients
- •- History of HIV, HCV or HBV infections. At the screening a specific test to assess the seronegativity to the viruses should be performed.
- •- No subjects with current active TB may be enrolled in the study.
- •-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 human chorionic gonadotropin
- •(hCG) laboratory test;
- •-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study;
- •-History of poor compliance.
研究者
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