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

NCT ID: NCT01338103

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pemphigus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Interventions

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Rituximab

intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leumit Health Services

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rabin Medical Center, Department of Dermatology

Locations

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Bullous diseases clinic, Department of dermatology, Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Daniel Mimouni, MD

Role: CONTACT

972-3-9376658

Facility Contacts

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Daniel Mimouni, MD

Role: primary

Other Identifiers

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5474

Identifier Type: -

Identifier Source: org_study_id

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