EUCTR2017-000435-13-DE进行中（未招募）1 期
Exploratory study to evaluate changes in inflammatory pattern and analysis for serum biomarkers in patients with active, moderate-to-severe hidradenitis suppurativa after 2-week and 6-week treatment with a TNF-alpha Inhibitor.
niversity Hospital Frankfurt for its Dermatology Department, Clinical Research0 个研究点目标入组 15 人开始时间: 2017年10月16日最近更新:
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
- 15
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
- •Main inclusion criteria
- •Diagnosis of HS for minimum of six months
- •Disease state diagnosed to be active and moderate to severe HS, requiring systemic therapy
- •No severe or otherwise clinically significant abnormalities found within the patient’s medical/medication history, nor during physical examination
- •Minimum of one previously failed or insufficiently responded to systemic therapy for HS
- •Women of childbearing age who are sexually active must use a highly effective form of contraception (Pearl Index < 1%) for the duration of the study
- •Negative test for tuberculosis (TB) according to local guidelines, obtained no more than three months prior to screening
- •Written informed consent and availability of any locally required authorization obtained from the subject, prior to performing any protocol-related procedures
- •Patients must be able and willing to comply with the requirements of this protocol
- •Age 18–65 years
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria
- •Previous use of Adalimumab (Humira®) or any other TNF-a inhibitors
- •Exclusion criteria related to IMP
- •According to SmPC
- •According to approval status of EMA
- •According to approval status of Adalimumab for treatement of HS in Germany
- •Known hypersensitivity to any component of the IMP
- •Exclusion criteria related to general health
- •Active dermatologic conditions that may confound the diagnosis of HS or would interfere with the assessment of treatment (e.g., atopic dermatitis, seborrhoic dermatitis, ichthyosis, psoriasis vulgaris, folliculitis)
- •History of a clinically significant infection four weeks prior to baseline visit, which, in the opinion of the investigator, may compromise the safety of the subject
- •History of chronic alcohol/drug abuse within the last 12 months before screening
- •Pregnant or breastfeeding women
- •Severe kidney insufficiency (GFR < 30 ml/min)
- •Any severe diseases that may, in the opinion of the investigator, interfere or worsen the hidradenitis suppurativa or result in safety concerns for patients being treated with an anti-TNF-alpha Inhibitor
- •History or presence of human immunodeficiency virus (HIV), and/or hepatitis B (HBV) or C virus (HCV) infections
- •History of active tuberculosis (TB), or untreated or inadequately treated latent TB (LTBI). Subjects must have a negative QuantiFERON, T-SPOT, or purified protein derivative (PPD) test, performed less than three months before the screening visit.
- •Any active medication which suppresses the immune system
- •History, current signs, symptoms, or diagnosis of a demyelinating disorder
- •History of or current Class III or IV congestive heart failure, as defined by the New York Heart Association,
- •History or current signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- •Current malignancy or history of any malignancy, except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ; no more than a total of three lifetime basal cell or squamous cell carcinomas permitted
- •Concurrent enrolment in another clinical trial, in which the subject is receiving an investigational product
- •Any major surgery in the last four weeks, that in the opinion of investigator, study related procedures or treatment with an anti-TNF-alpha inhibitor is contraindicated.
- •Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, including pleural effusions or ascites, which, in the opinion of the investigator pose an unacceptable safety risk
- •History of latex allergy
研究者
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