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Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

NCT ID: NCT00230204

Last Updated: 2006-02-16

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

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \[CMV\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (rheumatoid arthritis \[RA\], undifferentiated connective tissue disorder \[UCTD\], Sjogren, antiphospholipid syndrome - APS, vasculitides, systemic lupus erythematosus \[SLE\], polymyositis, Hashimoto, multiple sclerosis, primary biliary cirrhosis \[PBC\], etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).

Detailed Description

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The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \[CMV\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (RA, UCTD, Sjogren, antiphospholipid syndrome - APS, vasculitides, SLE, polymyositis, Hashimoto, multiple sclerosis, PBC, etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).

We will assess in our Center 100 patients with multiple sclerosis for the antibody profile of different infectious agents. Comparative assessments will be performed with normal matched subjects.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Definite multiple sclerosis

Exclusion Criteria

* Intravenous immune globulin (IVIg) treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Anat Achiron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel

Yehuda Shoenfeld

Role: PRINCIPAL_INVESTIGATOR

Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel

Locations

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Multiple Sclerosis Center, Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Anat Achiron, MD, PhD

Role: CONTACT

[email protected]
972-3-5303811

Yehuda Shoenfeld, MD

Role: CONTACT

[email protected]
972-3-5302652

Facility Contacts

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Anne Levy

Role: primary

[email protected]
972-3-5303932

Other Identifiers

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SHEBA-05-3868-AA-CTIL

Identifier Type: -

Identifier Source: org_study_id