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Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00230204
First received: September 29, 2005
Last updated: February 15, 2006
Last verified: January 2006
History of Changes
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
 Procedure: Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Definite multiple sclerosis

Exclusion Criteria:

  • Intravenous immune globulin (IVIg) treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230204

Contacts
Contact: Anat Achiron, MD, PhD 972-3-5303811 achiron@post.tau.ac.il
Contact: Yehuda Shoenfeld, MD 972-3-5302652 shoenfel@post.tau.ac.il

Locations
Israel
Multiple Sclerosis Center, Sheba Medical Center Recruiting
Ramat-gan, Israel, 52621
Contact: Anne Levy     972-3-5303932     annlevy@sheba.health.gov.il    
Principal Investigator: Anat Achiron, MD, PhD            
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230204     History of Changes
Other Study ID Numbers: SHEBA-05-3868-AA-CTIL
Study First Received: September 29, 2005
Last Updated: February 15, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Multiple sclerosis
Antibodies
Serum
 Infectious agents
Immunoglobulin G
Immunoglobulin M

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013