NCT01559155终止不适用
Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年11月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasmatic concentration of anti-proteasome autoantibodies (ng/ml)
研究概览
简要总结
The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.
详细描述
The secondary objectives of this study are:
To compare the following parameters between the 3 groups:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
To explore the potential relationships between:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
- plasmatic anti-proteasome auto-antibody concentrations
- measures of disease severity for dermatological auto-immune diseases
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is not taking systemic treatment
- •The patient has not been treated with topical steroids for more than 15 days.
- •For the bullous pemphigoid group:
- •clinical signs: erythematous-based lesions, especially on flexion areas of the arms and legs, not afflicting mucous membranes, and without atrophic scaring
- •histology: without epidermal acantholysis
- •For the pemphigus group:
- •patient with pemphigus
- •For the lupus group:
- •systemic lupus patients: presence of the 4 diagnostic criteria for systemic lupus erythematosus as defined by the American College of Rheumatology (amended 1997)
- •or characteristics of subacute cutaneous lupus: clinical, histological and immunological (anti-SSa)
- •or clinical and histological characteristics of chronic lupus
- •For the control group:
- •hospitalized patients with no history of auto-immune, inflammatory or evolving neoplastic disease
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •For patients with bullous pemphigoid, pemphigus or lupus:
- •The patient is taking systemic treatment
- •The patient has been taking topical steroids for more than 15 days.
- •For the controls:
- •autoimmune disease
- •inflammatory disease
- •evolving neoplastic disease
- •surgery during the last 6 months
结局指标
主要结局
Plasmatic concentration of anti-proteasome autoantibodies (ng/ml)
时间窗: baseline
次要结局
- CLASI score for lupus(baseline)
- Plasma proteasome concentration(baseline)
- % chymotrypsin-like plasma proteasome proteolytic activity(baseline)
- Disease duration (weeks)(baseline)
- % surface area(baseline)
- Puritis score(baseline)
- Pemphigus disease area index(baseline)
- the daily number of new lesions(baseline)
- % trypsin-like plasma proteasome proteolytic activity(baseline)
- Presence/absence of mucosal disease(baseline)
- Tissue DNA expression(baseline)
- Anti-desmogleine 1 and 3 antibody concentrations(baseline)
- % caspase-like plasma proteasome proteolytic activity(baseline)
- concentration of anti-PB18 antibodies, measured by ELISA(baseline)
- Immunohistochemistry(baseline)
- presence/absence of oral lesions(baseline)
- Presence/absence of Nikolsky's sign(baseline)
- Karnofsky's score (%)(baseline)
研究者
研究点 (1)
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