Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment (Bionat2)
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|ClinicalTrials.gov Identifier: NCT00942214|
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : March 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Natalizumab||Phase 4|
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-tailored medicine. Natalizumab, a monoclonal antibody has just received the EMEA approval for MS patients who do not respond to interferon treatment or who experience a severe disease course. Efficacy of the drug is outstanding with 37% of the patients completing the "disease free" definition after 2 years (7% in placebo group). On the other hand, natalizumab may be associated with severe adverse events such as progressive multifocal leucoencephalopathy and high costs. Overall, this emphasizes the need beyond current approval criteria to identify those patients with the best efficacy to safety ratio, a major public health issue.
Scientific aims The primary scientific aim is to define biomarkers that would allow predicting long term response to natalizumab.
Methodology; The investigators plan to conduct a 5 years study to search for the best predicting factors at the beginning of treatment and after 2 years. In this grant application the investigators will perform a multivariate analysis of clinical, MRI, and biological markers (neutralizing antibody, DNA, and mRNA expression) from baseline to 2 years. For feasibility reasons, long term follow up (5 years) and proteomics study will be performed in a second stage.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||March 2011|
- Drug: Natalizumab
300mg, IV, every 4 weeksOther Name: Tysabry (brand name)
- haplotypic frequency difference between responders and non-responders [ Time Frame: 12 and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942214
|service de neurologie, hôpital Purpan|
|Toulouse, France, 31059|
|Principal Investigator:||David Brassat, MD, PhD||University Hospital, Toulouse|