EUCTR2010-018559-84-DE进行中（未招募）不适用
AMBITIOUSAtopic Dermatitis Biomarker Identification Trial in Omalizumab UsageSingle- arm trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitis - AMBITIOUS
Medizinische Fakultät der technischen Universität Muenchen0 个研究点目标入组 20 人开始时间: 2010年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Age 18 years or above
- •Dermatological diagnosis of AD, SCORAD >=20
- •Eligible to receive systemic therapy for AD in accordance to local guidelines
- •Signed informed consent from patient
- •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
- •Evidence of skin disease other than AD (e.g. psoriasis) at the inclusion time
- •Treatment with systemic AD medications or any investigational drug within a 30-day washout period
- •Previous treatment with Omalizumab
- •Concomitant treatment with substances interfering with the immune system.
- •Permanent severe diseases, especially those affecting the immune system, except asthma
- •Pregnancy or breast feeding
- •History of food or drug related severe anaphylactoid or anaphylactic reaction(s)
- •History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- •History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- •Elevated serum IgE levels for reasons other than allergy and/or urticaria (e.g.: parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or clinical allergic bronchopulmonary aspergillosis).
- •Evidence of severe renal dysfunction or significant hepatic disease
- •Evidence for active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- •History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •Clinically significant laboratory abnormalities (not associated with AD) at Visit 1
- •Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to Omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin) or with known hypersensitivity to the trial’s rescue- or escalation-medication or related drugs (e.g.: loratadine, clemastine)
- •Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
- •Patients with serious psychiatric and/or psychological disturbances.
- •Patients with a history of drug or alcohol abuse.
- •Patients who are unable to complete a patient diary or complete questionnaires on paper
- •Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule.
研究者
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