Open-Label, Single Center Study to Evaluate the Immunopharmacological Effects of Rituximab in Patients With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Severity score (EASI)
研究概览
简要总结
Protocol Title: Immunopharmacological effects of Rituximab in atopic dermatitis
Study Phase: Investigator driven study
Study Design: Open-label, single center.
Primary Study Objective: To determine the efficacy, safety and immunopharmacological effects of Rituximab (anti-CD20) administered as a 1000mg intravenous infusion on days 1 and 15 to patients with atopic dermatitis.
Secondary Study Objective: To investigate key immunological parameters involved in the pathology of this common skin disease to interpret the clinical findings.
Number of Patients: 6
Study Population: Male and female patients, at least 18 years of age with atopic dermatitis, active inflammation, a severity score of 6-9 according to Langeland and Rajika.
Treatment Group: Rituximab will be administered as 1000 mg infusion intravenously at day 1 and 15, followed by a 24-week follow-up period.
Visit Schedule: Screening Visit (within 28 days prior to Visit 1) Treatment visits (Visits days 1, 3, 8, 15, 17) Follow-up Visits (Visits weeks 4, 8, 12, 16, 20, 24)
Visit 11/Early Termination Visit (if applicable) Visit 11 will serve as the Early Termination Visit for any patient who withdraws from the study between Visit 1 and 10.
Efficacy Parameters:
Clinical parameters:
EASI Patient Assessment of Pruritus / Pruritus score Physician Global Assessment (PGA) Photography
Laboratory analysis:
Differential blood count Total IgE, specific IgE (aeroallergen panel) Immunophenotyping of PBMC Lymphocyte proliferation following pan-T stimulation with PHA Cytokine release from blood T cells following pan-T stimulation with PHA
Skin tests Histopathology of skin biopsies
Safety Parameters: Physical examinations; vital signs; selected blood chemistry, including liver function tests, creatinine; white blood cell count (WBC; including total lymphocyte count); platelets, lymphocyte subset analysis; complement, immunoglobulins (IgA, IgM, IgG, IgE), monitoring for infections; monitoring for concomitant therapies; monitoring for adverse events.
详细描述
Investigator driven study
Immunopharmacological Effects of Rituximab in Atopic Dermatitis
Investigators
- Prof. Dr. Hans-Uwe Simon (Dept. of Pharmacology, University of Bern, Switzerland)
- Dr. Dagmar Simon, Prof. Dr. Lasse R. Braathen (Dept. of Dermatology, University of Bern, Switzerland)
SUMMARY
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must give written informed consent.
- •Must be at least 18 years of age.
- •Must have been diagnosed with atopic dermatitis fulfilling the diagnostic criteria of Hanfin and Rajka and having active inflammation.
- •Must have a severity score of 6-9 according to Langeland and Rajka.
- •Must have a PGA of "severe" or "very severe" and a pruritus score of "moderate" or "severe" at baseline.
排除标准
- •Patients with other skin diseases that might interfere with the evaluation of AD.
- •Patients with severe diseases of other organ systems (e.g. cardiovascular, liver, kidney, psychiatric, neurologic) that might put the patient on risk during the study or might interfere with the evaluations (in the opinion of the investigator).
- •Patient older than 65 years.
- •Systemic treatment for atopic dermatitis (e. g. corticosteroids, cyclosporine, mycophenolat-mofetil, interferon-gamma, UVB, UVA, PUVA) or systemic treatment with immunosuppressive/immunomodulating substances (e.g. azathioprin, methotrexate, biologics or hyposensitization -therapy) within 28 days prior to baseline.
- •Local treatment for atopic dermatitis with pimecrolimus/tacrolimus, steroids > class III, instable use of steroids class <III, emollients or local antiseptics/antibiotics within 14 days prior to day
- •Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to the first dose of Rituximab.
- •History of recurrent clinically significant infection.
- •Congenital or acquired immunodeficiency syndrome.
- •History of or a new diagnosis or treatment of an invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
- •For female patients, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception. Female patients considering becoming pregnant while in the study are excluded.
- •Female patients who are currently pregnant or breast-feeding.
- •Current enrollment in any other investigational drug study.
- •Previous participation in this study or previous studies with Rituximab.
研究组 & 干预措施
1
Patients with atopic dermatitis.
干预措施: Rituximab (Drug)
结局指标
主要结局
Severity score (EASI)
时间窗: 24 weeks
次要结局
- Immunological parameters(24 weeks)