Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatmen
Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
haplotypic frequency difference between responders and non-responders
12 and 24 months
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.0
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Serum Neurofilament Levels and PML Risk in Patients With Multiple Sclerosis Treated With Natalizumab.Neurol Neuroimmunol Neuroinflamm · 2021
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History
Started
Jun 2009
Main results due
Feb 2011
Finished
Mar 2011