Safety evaluation study about rituximab therapy for refractory pemphigus

未提供0 个研究点目标入组 20 人开始时间: 2017年5月11日最近更新: 2024年3月31日

试验速览

暂无简介。

•Patient diagnosed as pemphigus and relapse disease taking corticosteroids more than PSL 10mg/day.
•PDAI>=1
•Greater than or equal to 20 years of age and younger than or equal to 80 years of age.
•Able to understand and sign the Informed Consent Document.

•Women who may possibly be pregnant or pregnant and men who plan to impregnate a woman.
•Allergy to humanized monoclonal antibody and/or murine monoclonal antibody, murine derived component.
•Active major medical illnesses.
•Active infections.
•Past history of infection within 8weeks.
•Past history of taking antibiotics (oral ; within 2weeks, infusion ; 8weeks).
•Past history of bacteremia within 1 year.
•Past history of deep tissue infections and/or abscess.
•chronic and/or recurrent infections.
•Past history ofPatients who have or had malignancies.
•Past history of alcoholism and/or drug intoxication.
•Patients who have severe psychiatric disease.
•Past history of surgical operation within 4weeks.
•Past history of severe infection during taking immunosuppressive agent.
•vaccinated within 28weeks.
•Have laboratory parameters without Protocol-defined range.
•Infused Rituximab within 24weeks.
•Past history of Rituximab therapy more than 3times.
•taking other investigational drugs.
•ineffectiveness of past Rituximab therapy.

24-week safety after Rituximab therapy (CTCAE)

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发起方

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