Profiling Urticaria for the Identification of Subtypes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Results of a cell activating assay (BHRA)
研究概览
简要总结
The primary purpose of this study is to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria.
Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic spontaneous urticaria
- •disease duration > 6 weeks
- •signed and dated informed consent
- •age 18 years or older
- •Non sedating antihistamines may be used on an "on demand" basis throughout the study, in case of high urticaria activity [>50 wheals, and intense pruritus: urticaria activity score (UAS) of 6] or in case of an emergency. Patients may take either cetirizine 10 mg up to a maximum of 4 tablets per 24 hours or fexofenadine 180 mg up to a maximum of 4 tablets per 24 hours. The use of antihistamines and the reason has to be documented by the patient in the patient diary. Patients should avoid the use of antihistamines during the study and especially during the three days prior to skin testing
- •for female with childbearing potential: female will have to use a safe method of contraception to prevent pregnancy and will have to agree to continue this method of contraception during the whole study.
排除标准
- •intake of immunosuppressives 3 month before Screening Visit and during the course of the study. Immunosuppressives including ciclosporin, methotrexate, mycophenolate, azathioprine and cyclophosphamide need to be stopped at least 3 month before Screening Visit
- •intake of corticosteroids (e.g. oral, injection) 1 month before Screening Visit and during the course of the study. Corticosteroids need to be stopped at least 1 month before the Screening Visit.
- •Previous or present treatment with anti-IgE-antibodies including omalizumab (Xolair)
- •age below 18 years
- •use of tricyclic antidepressants (e.g. amitriptyline), doxepin, leukotriene antagonists (e.g. montelukast, trade name: singulair), H2 antihistamines (e.g. cimetidine, famotidine, ranitidine), sulphasalazine, dapsone, tranexamic acid, warfarin, heparin during the last 4 weeks before the Screening Visit and during the course of the study.
- •pregnancy, lactation or planned pregnancy during the study
- •mentally incapacitated subjects
- •patients protected by the law (adults under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated)
- •patients suffering from urticaria vasculitis
结局指标
主要结局
Results of a cell activating assay (BHRA)
时间窗: 21 days per patient
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Results of the ASST
时间窗: 21 days per patient
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Results of autoantibody-test (anti-IgE and anti-FcRI)
时间窗: 21 days per patient
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
次要结局
- Results of Urticaria activity score (UAS7)(21 days per patient)
- Results of HRQoL scores (CU-Q2oL, DLQI)(21 days per patient)
- Results of laboratory tests (Thyroid antibodies (anti-TPO +/- anti-thyreoglobulin); ANA; Rheumatoid factor; CRP; ESR; total IgE; T3,T4, TSH, diff BB, Helicobacter pylori stool antigen test or breath test; D-Dimer)(21 days per patient)
研究者
Marcus Maurer
Professor
Charite University, Berlin, Germany