Multiple SclerosisPhase 1NCT00230204
Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis
A Phase 1 study testing Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Apr 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Definite multiple sclerosis
Who cannot join
- Intravenous immune globulin (IVIg) treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Center, Sheba Medical Center
Ramat Gan, 52621
Anne Levy, 972-3-5303932, annlevy@sheba.health.gov.il
Anat Achiron, MD, PhD
About this study
Official title: Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits
- Keywords
- Multiple sclerosis, Antibodies, Serum, Infectious agents, Immunoglobulin G, Immunoglobulin M
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kitsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startSep 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Anat Achiron, MD, PhD, Principal investigator, Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, IsraelYehuda Shoenfeld, Principal investigator, Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230204
- Sponsor's protocol ID
- SHEBA-05-3868-AA-CTIL
- Status last verified
- Jan 2006
- First submitted
- 29 Sep 2005
- Last updated
- 16 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.
- ClinicalTrials.gov ID
- NCT00230204
- Acronym / sponsor ID
- SHEBA-05-3868-AA-CTIL
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Antibodies, Serum, Infectious agents, Immunoglobulin G, Immunoglobulin M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2005
- Study completion
- Apr 2006
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Definite multiple sclerosis
Key exclusion criteria (1 listed)
- Intravenous immune globulin (IVIg) treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits | Procedure or surgery | – |
Primary outcome
Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis
1 secondary outcome
Assess correlation between antibody levels to various infectious agents with clinical disease variables
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat Achiron, MD, PhD principal investigator
Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
Yehuda Shoenfeld principal investigator
Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Achiron, MD, PhD (972-3-5303811, achiron@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2006; AzTrials last refreshed its copy on 6 Nov 2026.