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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
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus focused on measuring Pemphigus, Rituximab, Cylex

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
April 17, 2011
Last Updated
April 29, 2011
Sponsor
Rabin Medical Center
Collaborators
Leumit Health Services
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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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