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Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Antibodies, Serum, Infectious agents, Immunoglobulin G, Immunoglobulin M

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Definite multiple sclerosis Exclusion Criteria: Intravenous immune globulin (IVIg) treatment

Sites / Locations

Multiple Sclerosis Center, Sheba Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis

Secondary Outcome Measures

Assess correlation between antibody levels to various infectious agents with clinical disease variables

Full Information

NCT ID

NCT00230204

First Posted

September 29, 2005

Last Updated

February 15, 2006

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00230204

Brief Title

Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

Official Title

Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple sclerosis, Antibodies, Serum, Infectious agents, Immunoglobulin G, Immunoglobulin M

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis

Secondary Outcome Measure Information:

Title

Assess correlation between antibody levels to various infectious agents with clinical disease variables

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Definite multiple sclerosis Exclusion Criteria: Intravenous immune globulin (IVIg) treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anat Achiron, MD, PhD

Phone

972-3-5303811

achiron@post.tau.ac.il

First Name & Middle Initial & Last Name or Official Title & Degree

Yehuda Shoenfeld, MD

Phone

972-3-5302652

shoenfel@post.tau.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anat Achiron, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yehuda Shoenfeld

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Multiple Sclerosis Center, Sheba Medical Center

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Levy

Phone

972-3-5303932

annlevy@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Anat Achiron, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

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