Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
Primary Purpose
Pemphigus
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Pemphigus focused on measuring Pemphigus, Rituximab, Cylex
Eligibility Criteria
Inclusion Criteria:
1. Pemphigus patients with moderate-severe disease
Exclusion Criteria:
- Pregnancy or lactation
- Woman of reproductive age not using birth control measures.
- Prior severe allergy or anaphylaxis with a human monoclonal antibody
- Heart failure
- Unstable angina or ischemic heart disease
- Uncontrolled arrhythmia
- HIV positive
- Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
- Severe dementia or a psychiatric illness
- Active acute infection
Sites / Locations
- Bullous diseases clinic, Department of dermatology, Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm Description
Outcomes
Primary Outcome Measures
Complete or partial remission off treatment (based on the consensus statement for pemphigus)
Secondary Outcome Measures
Full Information
NCT ID
NCT01338103
First Posted
April 17, 2011
Last Updated
April 29, 2011
Sponsor
Rabin Medical Center
Collaborators
Leumit Health Services
1. Study Identification
Unique Protocol Identification Number
NCT01338103
Brief Title
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
Collaborators
Leumit Health Services
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus
Keywords
Pemphigus, Rituximab, Cylex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.
Primary Outcome Measure Information:
Title
Complete or partial remission off treatment (based on the consensus statement for pemphigus)
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Pemphigus patients with moderate-severe disease
Exclusion Criteria:
Pregnancy or lactation
Woman of reproductive age not using birth control measures.
Prior severe allergy or anaphylaxis with a human monoclonal antibody
Heart failure
Unstable angina or ischemic heart disease
Uncontrolled arrhythmia
HIV positive
Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
Severe dementia or a psychiatric illness
Active acute infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Mimouni, MD
Phone
972-3-9376658
Facility Information:
Facility Name
Bullous diseases clinic, Department of dermatology, Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Mimouni, MD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
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