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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Leumit Health Services
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01338103
First received: April 17, 2011
Last updated: April 29, 2011
Last verified: March 2011
  Purpose

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
Pemphigus
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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01338103

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

Locations
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

No publications provided

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

Keywords provided by Rabin Medical Center:
Pemphigus
Rituximab
Cylex

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014