Infections and Autoimmunity: Autobodies Screening in Mult... | NCT00230204

Studies
Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis

NCT00230204

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Feb 16, 2006Estimated

Enrollment

100

Phase

Phase 1

Conditions

Multiple Sclerosis

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Sep 29, 2005

First Submission Date that Met QC Criteria

Sep 29, 2005

First Posted Date

Sep 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2006

Last Update Posted Date

Feb 16, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Assess correlation between antibody levels to various infectious agents with clinical disease variables

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Definite multiple sclerosis

Exclusion Criteria:

Intravenous immune globulin (IVIg) treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anat Achiron, MD, PhD	Contact	972-3-5303811		achiron@post.tau.ac.il
Yehuda Shoenfeld, MD	Contact	972-3-5302652		shoenfel@post.tau.ac.il

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple Sclerosis Center, Sheba Medical Center	Recruiting	Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided