Treatment of Pemphigus Patients With Rituximab 1000mgX2 a... | NCT01338103

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

NCT01338103

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

May 2, 2011Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Pemphigus

Interventions

Rituximab

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Apr 17, 2011

First Submission Date that Met QC Criteria

Apr 17, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Name	Class
Leumit Health Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab	Experimental		Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.	Rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete or partial remission off treatment (based on the consensus statement for pemphigus)		6 months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Mimouni, MD	Contact	972-3-9376658

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bullous diseases clinic, Department of dermatology, Rabin Medical Center	Recruiting	Petah Tikva		49100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010392	Pemphigus

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided