Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

February 15, 2006 updated by: Sheba Medical Center

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat-gan, Israel, 52621
        • Recruiting
        • Multiple Sclerosis Center, Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Anat Achiron, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Definite multiple sclerosis

Exclusion Criteria:

  • Intravenous immune globulin (IVIg) treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Anat Achiron, MD, PhD, Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
  • Principal Investigator: Yehuda Shoenfeld, Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 15, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-05-3868-AA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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