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NCT00230204 Clinical Trial

Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00230204
Other study ID # SHEBA-05-3868-AA-CTIL
Secondary ID
Status Recruiting
Phase Phase 1
First received September 29, 2005
Last updated February 15, 2006
Start date September 2005
Est. completion date April 2006

Study information
Verified date January 2006
Source Sheba Medical Center
Contact Anat Achiron, MD, PhD
Phone 972-3-5303811
Email achiron@post.tau.ac.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Definite multiple sclerosis

Exclusion Criteria:

- Intravenous immune globulin (IVIg) treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Multiple Sclerosis Center, Sheba Medical Center Ramat-gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis
Secondary Assess correlation between antibody levels to various infectious agents with clinical disease variables
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