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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01338103
Recruitment Status : Unknown
Verified March 2011 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : April 19, 2011
Last Update Posted : May 2, 2011
Sponsor:
Collaborator:
Leumit Health Services
Information provided by:
Rabin Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pemphigus Drug: Rituximab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rituximab Drug: Rituximab
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.


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

Eligibility Criteria
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Information from the National Library of Medicine

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338103


Contacts
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Contact: Daniel Mimouni, MD 972-3-9376658

Locations
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Israel
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
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Responsible Party: Daniel Mimouni MD, Rabin Medical Center, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01338103    
Other Study ID Numbers: 5474
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: March 2011
Keywords provided by Rabin Medical Center:
Pemphigus
Rituximab
Cylex
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents