Safety evaluation study about rituximab therapy for refractory pemphigus - Rituximab therapy for refractory pemphigus

Keio University, School of Medicine0 sites20 target enrollmentMarch 8, 2017

Conditionspemphigus

Overview

No summary available.

Registry

who.int

Start Date

March 8, 2017

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\) Women who may possibly be pregnant or pregnant and men who plan to impregnate a woman 2\) Allergy to humanized monoclonal antibody and/or murine monoclonal antibody, murine derived component 3\) Active major medical illnesses 4\) Active infections 5\) Past history of infection within 8weeks 6\) Past history of taking antibiotics (oral ; within 2weeks, infusion ; 8weeks) 7\) Past history of bacteremia within 1 year 8\) Past history of deep tissue infections and/or abscess 9\) chronic and/or recurrent infections 10\) Past history ofPatients who have or had malignancies 11\) Past history of alcoholism and/or drug intoxication 12\) Patients who have severe psychiatric disease 13\) Past history of surgical operation within 4weeks 14\) Past history of severe infection during taking immunosuppressive agent 15\) vaccinated within 28weeks 16\) Have laboratory parameters without Protocol\-defined range 17\) Infused Rituximab within 24weeks 18\) Past history of Rituximab therapy more than 3times 19\) taking other investigational drugs 20\) ineffectiveness of past Rituximab therapy