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

Not Applicable

• Conditions: Pemphigus
• Interventions: Drug: Rituximab

• Registration Number: NCT01338103
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2011-03
• Study First Submitted: 2011-04-17
• Study First Submitted QC: 2011-04-17
• Study First Posted: 2011-04-19
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bullous diseases clinic, Department of dermatology, Rabin Medical Center; 🇮🇱 Petah Tiqva, Israel