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TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00228228
Recruitment Status : Unknown
Verified August 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : September 28, 2005
Last Update Posted : August 29, 2006
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date August 29, 2006
Study Start Date  ICMJE May 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
  • The rate of progression to definite MS (second attack) during the study
  • Time to progression to definite MS (second attack)
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • 1.The rate of progression to definite MS (second attack) during the study.
  • 2.Time to progression to definite MS (second attack.
Change History Complete list of historical versions of study NCT00228228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
  • Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs
  • Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F)
  • The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • 1. Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs.
  • 2. Change in total volume of new GD enhancing lesions from two baseline MRI’s (B) to the final MRI’s (F).
  • 3. The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
Official Title  ICMJE T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
Brief Summary

In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first clinical attack. It is of the utmost importance to evaluate the treatment effects at the onset of disease, i.e. in patients with probable MS, in order to evaluate whether early treatment can prevent the second attack (conversion to definite MS). Moreover, at disease onset, the immunological process of epitope spreading associated with the exposure of the immune system to myelin antigens is still limited. With additional attacks, increased recognition of new self-determinants of encephalitogenic peptides presented to the immune system during the inflammatory process occurs, and enhances further disease activity. The aim of the early TCV treatment approach is to stop this process as early as possible, during the onset of the disease, thus preventing additional attacks and disease progression.

We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging (MRI) parameters in patients with probable MS.

Detailed Description

Inclusion criteria:

  • Age: 15 - 50 years.
  • Three months within the acute onset of neurological symptoms suggestive of the first attack of multiple sclerosis.
  • Diagnosis of CPMS C3 (Poser criteria).
  • Positive brain MRI according to Fazekas criteria.
  • Negative pregnancy test and use of effective contraceptive for female patients who are sexually active.
  • Signed written informed consent.

Exclusion criteria:

  • Blood tests suggestive of other autoimmune diseases.
  • Known allergic reactions to MRI contrast media.
  • A clear regression of the neurological symptoms after the first attack that suggests a primary-progressive course.
  • Corticosteroid treatment in the previous 4 weeks (28 days).
  • Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone or cyclosporine.
  • Previous treatment with interferon beta 1a or 1b, copolymer-1, IVIg, plasmapheresis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Biological: T cell vaccination
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 27, 2005)
80
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 15-50
  • Three months within the acute onset of neurological symptoms suggestive of multiple sclerosis
  • Diagnosis of clinically probable MS (CPMS) C3: 1 attack with at least 1 clinical manifestation in addition to positive brain MRI as defined in the protocol, signifying paraclinical evidence (Poser criteria 1983).
  • Positive Brain MRI: at least 4 focal lesions involving the white matter of 3 lesions if one is periventricular > 3mm diameter, each
  • Negative pregnancy test and use of effective contraceptives for female patients who are sexually active.
  • Signed written informed consent.

Exclusion Criteria:

  • Blood tests suggestive of other autoimmune diseases
  • Known allergic reaction to MRI contrast media.
  • A clear regression of the neurological symptoms after the first attack that excludes a primary progressive course.
  • Corticosteroid treatment in the previous 4 weeks.
  • Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone, or cyclosporine.
  • Previous treatment with interferon beta 1a or 1b copolymer-1 IVIg, plasmapheresis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228228
Other Study ID Numbers  ICMJE SHEBA-01-2490-AA-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anat Achiron, MD, PhD Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
Principal Investigator: Mathilda Mandel, MD Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel
PRS Account Sheba Medical Center
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP