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

Multiple Sclerosis Clinical Trial

Official title: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00228228
• Study type: Interventional
• Source: Sheba Medical Center
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2002
• Completion date: December 2006