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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.
One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.
The objective of this study is to assess the efficacy in term of ARR and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Interval Dosing (SID) | Patients continuing Natalizumab treatment with standard interval dosing defined as > 11 infusions per year |
| |
| Extended Interval Dosing (EID) | Patients switching to extended interval dosing defined as ≤ 10 infusions per year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab Injection [Tysabri] | Drug | Natalizumab infusion interval according to local practice defining the patient's group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Ratio | relapse rate per patient per year | baseline to 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Disability progression | Increase in EDSS score during the follow-up period | baseline to 12 month follow-up |
| NEDA-3 achievement | Estimation of the proportion of patients achieving NEDA-3 criteria at the end of the follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | Description of PML cases and variations in anti-JCV antibody status when available | baseline to 12 month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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Patients receiving Natalizumab as disease-modifying monotherapy for RRMS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, CHU Bobigny-Avicenne | Bobigny | 93000 | France | |||
| Department of Neurology, CHU de Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36763307 | Derived | Pelle J, Briant AR, Branger P, Derache N, Arnaud C, Lebrun-Frenay C, Cohen M, Mondot L, De Seze J, Bigaut K, Collongues N, Kremer L, Ricard D, Bompaire F, Ohlmann C, Sallansonnet-Froment M, Ciron J, Biotti D, Pignolet B, Parienti JJ, Defer G. Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort. Neurol Ther. 2023 Apr;12(2):529-542. doi: 10.1007/s40120-023-00440-5. Epub 2023 Feb 10. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| baseline to 12 month follow-up |
| Radiological activity | Detection of increase MRI activity defined as new or enlarged T2 lesions and/or new gadolinium enhancing lesions | baseline to 12 month follow-up |
| Caen |
| 14000 |
| France |
| Department of Neurology, Percy Military Hospital | Clamart | 92140 | France |
| Department of Neurology, CHU Nice | Nice | 06000 | France |
| Department of Neurology, CHU Toulouse Purpan | Toulouse | 31300 | France |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |