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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00228228
First received: September 26, 2005
Last updated: August 27, 2006
Last verified: August 2006

September 26, 2005
August 27, 2006
May 2002
Not Provided
  • The rate of progression to definite MS (second attack) during the study
  • Time to progression to definite MS (second attack)
  • 1.The rate of progression to definite MS (second attack) during the study.
  • 2.Time to progression to definite MS (second attack.
Complete list of historical versions of study NCT00228228 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
Not Provided
Not Provided
 
TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Multiple Sclerosis
Biological: T cell vaccination
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2006
Not Provided

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.
Both
15 Years to 50 Years
No
Not Provided
Israel
 
NCT00228228
SHEBA-01-2490-AA-CTIL
Not Provided
Not Provided
Sheba Medical Center
Not Provided
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
Sheba Medical Center
August 2006

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