TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis|
- The rate of progression to definite MS (second attack) during the study
- Time to progression to definite MS (second attack)
- 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)
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||December 2006|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228228
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|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|