Clinical Trials For Genital Herpes Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

This study is currently recruiting participants.

Verified by Sheba Medical Center, January 2006

First Received: September 29, 2005   Last Updated: February 15, 2006   History of Changes

Sponsor:

Sheba Medical Center

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00230204

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 I


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

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:


MedlinePlus related topics: Autoimmune Diseases Multiple Sclerosis

Drug Information available for: Immunoglobulins Globulin, Immune

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:

Autoimmune Diseases

Demyelinating Diseases

Immune System Diseases

Immunologic Factors

Nervous System Diseases

Physiological Effects of Drugs

Sclerosis

Pharmacologic Actions

Antibodies

Multiple Sclerosis

Pathologic Processes

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Immunoglobulins


ClinicalTrials.gov processed this record on June 15, 2010

Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

This study is currently recruiting participants.

Verified by Sheba Medical Center, January 2006

First Received: September 29, 2005   Last Updated: February 15, 2006   History of Changes

Sponsor:

Sheba Medical Center

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00230204

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 I


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

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:


MedlinePlus related topics: Autoimmune Diseases Multiple Sclerosis

Drug Information available for: Immunoglobulins Globulin, Immune

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:

Autoimmune Diseases

Demyelinating Diseases

Immune System Diseases

Immunologic Factors

Nervous System Diseases

Physiological Effects of Drugs

Sclerosis

Pharmacologic Actions

Antibodies

Multiple Sclerosis

Pathologic Processes

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Immunoglobulins


ClinicalTrials.gov processed this record on June 15, 2010