Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

Phase 1

• Conditions: Multiple Sclerosis

• Registration Number: NCT00230204
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-29
• Study First Submitted QC: 2005-09-29
• Study First Posted: 2005-09-30
• Status Verified: 2006-01
• Last Update Submitted: 2006-02-15
• Last Update Posted: 2006-02-16
• Study Completion: 2006-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Definite multiple sclerosis

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Exclusion Criteria

• Intravenous immune globulin (IVIg) treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Multiple Sclerosis Center, Sheba Medical Center; 🇮🇱 Ramat-gan, Israel