Status:
COMPLETED
Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 subop...
Detailed Description
Current state of knowledge of the topic of the project and The general interest of the project; Pharmacogenomic aims to determine biomarkers related to treatment response, a step toward patient-tailor...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00942214
Start Date
June 1 2009
End Date
March 1 2011
Last Update
March 30 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
service de neurologie, hôpital Purpan
Toulouse, France, 31059