Title
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test
Phase
N/ALead Sponsor
Tel Aviv UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
PemphigusIntervention/Treatment
rituximab ...Study Participants
10The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.
Inclusion Criteria: 1. Pemphigus patients with moderate-severe disease Exclusion Criteria: Pregnancy or lactation Woman of reproductive age not using birth control measures. Prior severe allergy or anaphylaxis with a human monoclonal antibody Heart failure Unstable angina or ischemic heart disease Uncontrolled arrhythmia HIV positive Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies. Severe dementia or a psychiatric illness Active acute infection