NCT00230204

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 16, 2006

Status Verified

January 1, 2006

First QC Date

September 29, 2005

Last Update Submit

February 15, 2006

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisAntibodiesSerumInfectious agentsImmunoglobulin GImmunoglobulin M

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Assess correlation between antibody levels to various infectious agents with clinical disease variables

Interventions

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Definite multiple sclerosis

You may not qualify if:

  • Intravenous immune globulin (IVIg) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center, Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

Central Study Contacts

Anat Achiron, MD, PhD

CONTACT

972-3-5303811achiron@post.tau.ac.il

Yehuda Shoenfeld, MD

CONTACT

972-3-5302652shoenfel@post.tau.ac.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 29, 2005

First Posted

September 30, 2005

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

February 16, 2006

Record last verified: 2006-01

Locations

IL(1)