Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Information from blood samples may help us for choosing the best treatment in future personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is not consensual. The investigators hypothesized that biological information could rationalize choice and thus designed a prospective open label trial to test biological markers before treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Natalizumab

Criteria

Inclusion Criteria:

• Patients between the ages of 18 and 55 years.

• Diagnosis of relapsing multiple sclerosis according to McDonald criteria.

• EDSS score of 0 to 5.0 on the EDSS scale. One of the following 2 items:

1. Patients who have failed to respond to a full and adequate course of a beta-interferon. Patients have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion.

2. Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Exclusion Criteria:

• Hypersensitivity to natalizumab or to any of the excipients.

• Progressive Multifocal Leukoencephalopathy (PML).

• Increased risk of opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide within 1 year before Tysabri.

• Combination with beta-interferons or glatiramer acetate.

• Known active malignancies, except for patients with cutaneous basal cell carcinoma.

• Children and adolescents.