EUCTR2010-024152-29-DE进行中（未招募）1 期
Canakinumab for Behçet`s Disease Resistant to Standard Treatment(CanBeDisT) - CanBeDisT
niversity Hospital of Tübingen0 个研究点目标入组 10 人开始时间: 2011年6月21日最近更新:
适应症
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
- 10
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 with BD fulfilling the international study group criteria (ISBD) from 1990 with active disease defined as BDCAF >3 and/or posterior uveitis score >2
- •Treatment resistant to standard treatment according to EULAR guidelines (colchicine, azathioprine, methotrexate (plus glucocorticosteroids), in case of ocular disease also TNF-antagonists or interferon-alpha.
- •Age = 18 years = 65 years
- •Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
- •Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and at the end of the trial and must not be lactating.
- •Female subjects of non-childbearing potential must meet at least one of the
- •following criteria:
- •Postmenopausal females, defined as:
- •Females over the age of 60 years.
- •Females who are 45 to 60 years of age must be amenorrhoic for at least 2 years.
- •Females who had a hysterectomy and/or bilateral oophorectomy.
- •Protocol: CanBeDisT Version 1.0 29.04.2011
- •Subjects of both genders with reproductive potential who are sexually active
- •agree to use contraception throughout the course of the study and for at least
- •3 months after completion of their study participation.
- •Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
- •Negative PPD or Quantiferon test and uneventful chest X ray from last 12
- •months (negative for tuberculosis)
- •Negative serology for HIV, hepatitis ABC
- •Prior Medication:
- •Patients with non-ocular, non-severe disease (mucocutaneuous, arthritis,
- •thrombophlebitis) must have had colchicine and/or azathioprine without
- •sufficient efficacy before entering the study.
- •Patients with ocular BD must have been treated at least with azathioprine,
- •and/or cyclosporin A plus glucocorticosteroids without effect before entering
- •the study. Interferon-alpha and TNF antagonists may have also been
- •ineffective before entering the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients under 18 years
- •Severe, life threatening BD manifestations (pulmonary arterial aneurysms,
- •Female patients not willing to use contraceptives
- •Signs of tuberculosis in chest x-ray during the past 12 months before study
- •Hemoglobin < 8 g/dl, WBC < 3000/ul, platelet count < 100.000/ul, GFR/MDRD
- •< 50 ml/min/1,73m2, AST/ALT > 2x upper normal limit, alkaline phosphatase >
- •2x upper normal limit
- •Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
- •History of malignancy within 5 years prior to study entry other than carcinoma
- •in situ of the cervix, or adequately treated, non-metastatic squamous or basal
- •cell carcinoma of the skin
- •History of severe allergic reaction to humanized or murine monoclonal
- •Fever or infection requiring antibiotic treatment within 3 weeks prior to
- •screening, history of recurrent infection or predisposition to infections
- •Immunodeficiency
- •Demyelinating disease
- •Known presence or suspicion of active or recurrent bacterial, fungal or viral
- •infection at the time of enrollment, where an IL-1 blocker might have an impact
- •on underlying severe immunocompromising diseases as e.g. evidence of
- •Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C
- •infections (based on history and/or clinical findings).
- •One of the risk factors for TB such as but not limited or exclusive to:
- •a. History of any of the following: residence in a congregate setting (e.g.
- •jail or prison, homeless shelter, or chronic care facility), substance
- •abuse (e.g. injection or noninjection); health-care workers with
- •unprotected exposure to patients who are at high risk of TB or patients
- •with TB disease before the identification and correct airborne
- •precautions of the patient, or
- •b. Close contact (i.e. share the same air space in a household or other
- •enclosed environment for a prolonged period (days or weeks, not
- •minutes or hours)) with a person with active pulmonary TB disease
- •within the last 12 months.
- •History of ongoing, chronic or recurrent infectious disease or evidence of
- •tuberculosis infection determined as defined by local guidelines/ local medical
- •practice. If presence of tuberculosis is established then treatment (according
- •to local guidelines) must have been completed prior to randomization.
- •Significant medical problems, including but not limited to the following:
- •uncontrolled hypertension (= 200/105 mmHg), congestive heart failure [New
- •York Heart Association Stage D], uncontrolled diabetes type I and II (recent
- •blood glucose > 300 mg/dl), thyroid disease (unless the patient is taking a
- •stable dose of thyroid hormone or anti-thyroid medications (hyperthyroidism)
- •for at least 12 weeks), which in the opinion of the Investigator will exclude the
- •patient from the study (can be discussed on a case by case basis with
- •Life vaccine within 3 months prior to screening. Live seasonal flu /H1N1
- •vaccines are permitted > 2 weeks prior to screening
- •Major surgery within 4 weeks prior to week 1 (injection of canakinumab)
- •Participation in an investigational drug trial within 4 weeks prior to screening
- •Presence of absolute contraindications for canakinumab as mentioned in the
- •product information (Appendix 1)
- •Presence of relative contraindications for canakinumab as mentioned in the
- 另有 2 项未显示
研究者
相似试验
进行中（未招募）
不适用
Treatment with bevacizumab and irinotecan in patients with recurrent or refractory high grade glioma after conventional treatment. - NDhigh grade gliomaMedDRA version: 9.1Level: LLTClassification code 10065443Term: Malignant gliomaEUCTR2009-012582-64-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
已完成
2 期
Bosentan (Tracleer®) in patients with Behçet*s disease: a Pilot Study.NL-OMON31428Academisch Medisch Centrum20
已完成
1 期
Anakinra for Behcet s DiseaseAutoimmune Connective Tissue DisorderImmune System DiseasesNCT01441076National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)6
进行中（未招募）
1 期
Immunochemotherapy as new tratment for older patients with Hodgkin LymphomaEUCTR2013-003990-89-FIniversity of Cologne70
已完成
1 期
Safety and tolerability study of OP-724 in liver cirrhosis patients by HIV/HCV with hemophilia. (Phase I).iver cirrhosis caused by HIV/HCV co-infected with hemophiliaLiver Cirrhosis, HemophiliaD008103JPRN-jRCT2031200266Kimura Kiminori6