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

NCT00228228 | Unknown Phase 3

• 1 other identifier: SHEBA-01-2490-AA-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; T-cell vaccination; Autoreactive T cells

Outcome Measures

Primary Outcomes (2)

• The rate of progression to definite MS (second attack) during the study

• Time to progression to definite MS (second attack)

Secondary Outcomes (3)

• 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)

Interventions

T cell vaccination BIOLOGICAL

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: May 1, 2002
• Study Completion: December 1, 2006
• Last Updated: August 29, 2006

Record last verified: 2006-08

Locations

IL (1)