ETCABio - Evaluation of Skin Tests in Biotherapy Allergies
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.
研究概览
简要总结
The primary objective is to determine, in non-allergic patients treated with biotherapy, the maximum non-irritant concentration of the biotherapy that can be used in allergologic skin tests (prick tests and intradermal tests) for patients suspected of hypersensitivity to the said biotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.
- •Subjects covered by or having the rights to medical care assurance
- •Written informed consent obtained from subject
- •If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).
排除标准
- •Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.
- •Poor understanding of the French language.
- •Pregnancy, breastfeeding* (For women of childbearing age, the absence of pregnancy will be confirmed by a blood pregnancy test (unless already conducted as part of the care or if pregnancy is ruled out).
- •Persons in detention by judicial or administrative decision
- •Person admitted to a health or social establishment for purposes other than research
- •Person subject to a legal protection measure
结局指标
主要结局
For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.
For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.
次要结局
- A delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours or one week after injection, or if a systemic reaction occurs following biotherapy administration. Patients will be contacted by phone to confirm the presence or absence of a delayed local reaction, and if necessary, a photograph taken during a consultation with the allergologist investigator or in a video consultation will confirm the reaction.
研究者
investigator coordinnating
Scientific
Centre Hospitalier Universitaire D'Angers