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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338103

Enrollment

Registered

2011-04-19

Start date

2010-01-31

Completion date

2012-06-30

Last updated

2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus

Keywords

Pemphigus, Rituximab, Cylex

Brief summary

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.

Interventions

DRUGRituximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete or partial remission off treatment (based on the consensus statement for pemphigus)	6 months after treatment

Countries

Israel

Contacts

Primary ContactDaniel Mimouni, MD

972-3-9376658

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026