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

Pemphigus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01338103
• Other study ID #: 5474
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2011
• Last updated: April 29, 2011
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: Rabin Medical Center
• Contact: Daniel Mimouni, MD
• Phone: 972-3-9376658
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pemphigus

Intervention

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

Locations

Country	Name	City	State
Israel	Bullous diseases clinic, Department of dermatology, Rabin Medical Center	Petah Tiqva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Leumit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete or partial remission off treatment (based on the consensus statement for pemphigus)		6 months after treatment	No