Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Rabin Medical Center.
Recruitment status was:  Recruiting
Leumit Health Services
Information provided by:
Rabin Medical Center Identifier:
First received: April 17, 2011
Last updated: April 29, 2011
Last verified: March 2011
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.

Condition Intervention
Drug: Rituximab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Complete or partial remission off treatment (based on the consensus statement for pemphigus) [ Time Frame: 6 months after treatment ]

Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab Drug: Rituximab
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01338103

Contact: Daniel Mimouni, MD 972-3-9376658

Bullous diseases clinic, Department of dermatology, Rabin Medical Center Recruiting
Petah Tiqva, Israel, 49100
Contact: Daniel Mimouni, MD         
Sponsors and Collaborators
Rabin Medical Center
Leumit Health Services
  More Information

Responsible Party: Daniel Mimouni MD, Rabin Medical Center, Department of Dermatology Identifier: NCT01338103     History of Changes
Other Study ID Numbers: 5474
Study First Received: April 17, 2011
Last Updated: April 29, 2011

Keywords provided by Rabin Medical Center:

Additional relevant MeSH terms:
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 28, 2017