Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex

Rabin Medical Center10 enrolled

Overview

The 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pemphigus

Interventions

RituximabDRUG

intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Pemphigus patients with moderate-severe disease Exclusion Criteria: 1. Pregnancy or lactation 2. Woman of reproductive age not using birth control measures. 3. Prior severe allergy or anaphylaxis with a human monoclonal antibody 4. Heart failure 5. Unstable angina or ischemic heart disease 6. Uncontrolled arrhythmia 7. HIV positive 8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies. 9. Severe dementia or a psychiatric illness 10. Active acute infection

Locations (1)

Bullous diseases clinic, Department of dermatology, Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Outcomes

Primary Outcomes

Complete or partial remission off treatment (based on the consensus statement for pemphigus)

Time frame: 6 months after treatment

Central Contacts

Daniel Mimouni, MD

CONTACT

972-3-9376658

Data from ClinicalTrials.gov

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