Fiche traitement
natalizumab
Biogen • SEP
Suivi actif
Phase 1
Résumé
natalizumab est développé par Biogen. Le traitement est actuellement en Phase 1. Il est associé à SEP. . Le statut actuel est : suivi actif.
À vérifier
Non renseigné
Phase 1
Biogen
United States
The primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS.
2014-09-05
Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique
Phase 1
Début phase actuelle
Non disponible dans les sources synchronisées
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé
Objectif scientifique de l’étude
classification automatique vérifiable
Confiance automatique : 59%
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Indices détectés : edss → Ralentissement de la progression
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT00559702, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Contrôle de cohérence : 85/100
L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.
Transparence et qualité de la fiche
données vérifiablesClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2014-09-05
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une source
Donnée normalisée automatiquement
Interprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultatÉtat de l’étudeTerminée
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectifPhase enregistréePhase 1
Études associées1
Publications associées19
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
23 événement(s) daté(s)Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
| Date | Événement | Source |
|---|---|---|
| 2007-10-01 | Début de l’étudeNCT00559702 | Registre d’essai clinique |
| 2011-11-01 | Fin de l’étude prévue / enregistréeNCT00559702 | Registre d’essai clinique |
| 2014-09-05 | Dernière mise à jour des donnéesnatalizumab | Biomedical Watch |
| 2026-07-10 | PublicationThe impact of age on efficacy and safety of disease modifying treatment-insights from the Austrian Multiple Sclerosis Treatment Registry. | Journal of neurology |
| 2026-07-14 | PublicationReal-world pharmacovigilance analysis of the association between multiple sclerosis disease-modifying therapies and intervertebral disc herniation. | Frontiers in pharmacology |
| 2026-07-18 | PublicationThe Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis. | Neurology(R) neuroimmunology & neuroinflammation |
| 2026-08-08 | PublicationThe 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis. | Multiple sclerosis and related disorders |
| 2026-08-08 | PublicationDifferential safety profiles of disease-modifying therapies in MS: Age- and sex-based analysis from a real-world cohort. | Multiple sclerosis and related disorders |
| 2026-08-08 | PublicationEvaluating the efficacy and safety of transitioning patients with multiple sclerosis from natalizumab to ocrelizumab (OCTAVE). | Multiple sclerosis (Houndmills, Basingstoke, England) |
| 2026-08-08 | PublicationReal-world COVID-19 immunity in multiple sclerosis (CoVaR-MS): A longitudinal follow up study. | Multiple sclerosis and related disorders |
| 2026-08-08 | PublicationNatalizumab is associated with improved relapse outcomes and lower healthcare utilization versus ocrelizumab in treatment-naïve people with multiple sclerosis. | Journal of medical economics |
| 2026-08-08 | PublicationUrinary tract infections, urosepsis, and multiple sclerosis disease modifying therapies: a disproportionality analysis of the FDA Adverse Event Reporting System. | Multiple sclerosis and related disorders |
| 2026-08-13 | PublicationTreatment persistence in paediatric-onset multiple sclerosis: A Swedish nationwide registry study. | Multiple sclerosis (Houndmills, Basingstoke, England) |
| 2026-08-13 | PublicationSafety and efficacy of oral cladribine in relapsing multiple sclerosis: a systematic review and meta-analysis. | BMC neurology |
| 2026-08-13 | PublicationCladribine treatment in pediatric-onset multiple sclerosis: real-world clinical outcomes and safety insights. | Frontiers in immunology |
| 2026-08-13 | PublicationRetinal atrophy in multiple sclerosis is similar with extended versus standard interval natalizumab therapy. | Multiple sclerosis journal - experimental, translational and clinical |
| 2026-08-13 | PublicationNatalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. | Health technology assessment (Winchester, England) |
| 2026-08-16 | Création de l’enregistrementNCT00559702 | Registre d’essai clinique |
| 2026-08-16 | PublicationAppendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. | Multiple sclerosis and related disorders |
| 2026-08-16 | PublicationReal-world siponimod use in secondary progressive multiple sclerosis: the RESYZE study. | Therapeutic advances in neurological disorders |
| 2026-08-16 | PublicationComparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study. | Journal of neurology, neurosurgery, and psychiatry |
| 2026-08-16 | PublicationLongitudinal evolution of JC virus serological index in multiple sclerosis patients treated with natalizumab: Observational dynamics in a decade-spanning real-world cohort (2014-2024). | Clinical neurology and neurosurgery |
| 2026-08-16 | PublicationFrom options to decisions: an innovative model for treatment sequencing in relapsing-remitting multiple sclerosis. | Journal of medical economics |
Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés
1 essai(s)
Début phase actuelle
Non disponible dans les sources synchronisées
| NCT | Titre | Phase | Statut administratif | Pays | Sponsor |
|---|---|---|---|---|---|
| NCT00559702 | Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) | Phase 1 | COMPLETED | United States | Biogen |
Publications liées
19 publication(s)Publications liées
19 publication(s)| Titre | PMID | DOI | Journal | Date |
|---|---|---|---|---|
| Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. Voir source | 41785834 | 10.1016/j.msard.2026.107106 | Multiple sclerosis and related disorders | |
| Real-world siponimod use in secondary progressive multiple sclerosis: the RESYZE study. Voir source | 42602134 | 10.1177/17562864261472650 | Therapeutic advances in neurological disorders | |
| Comparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study. Voir source | 42161588 | 10.1136/jnnp-2026-338424 | Journal of neurology, neurosurgery, and psychiatry | |
| Longitudinal evolution of JC virus serological index in multiple sclerosis patients treated with natalizumab: Observational dynamics in a decade-spanning real-world cohort (2014-2024). Voir source | 42229340 | 10.1016/j.clineuro.2026.109522 | Clinical neurology and neurosurgery | |
| From options to decisions: an innovative model for treatment sequencing in relapsing-remitting multiple sclerosis. Voir source | 42339705 | 10.1080/13696998.2026.2688699 | Journal of medical economics | |
| Treatment persistence in paediatric-onset multiple sclerosis: A Swedish nationwide registry study. Voir source | 42218618 | 10.1177/13524585261448789 | Multiple sclerosis (Houndmills, Basingstoke, England) | |
| Safety and efficacy of oral cladribine in relapsing multiple sclerosis: a systematic review and meta-analysis. Voir source | 41420217 | 10.1186/s12883-025-04514-9 | BMC neurology | |
| Cladribine treatment in pediatric-onset multiple sclerosis: real-world clinical outcomes and safety insights. Voir source | 42148068 | 10.3389/fimmu.2026.1727925 | Frontiers in immunology | |
| Retinal atrophy in multiple sclerosis is similar with extended versus standard interval natalizumab therapy. Voir source | 42571199 | 10.1177/20552173261475496 | Multiple sclerosis journal - experimental, translational and clinical | |
| Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. Voir source | 42579606 | 10.3310/GJHT1811 | Health technology assessment (Winchester, England) | |
| The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis. Voir source | 31901758 | 10.1016/j.msard.2019.101863 | Multiple sclerosis and related disorders | |
| Differential safety profiles of disease-modifying therapies in MS: Age- and sex-based analysis from a real-world cohort. Voir source | 42107470 | 10.1016/j.msard.2026.107220 | Multiple sclerosis and related disorders | |
| Evaluating the efficacy and safety of transitioning patients with multiple sclerosis from natalizumab to ocrelizumab (OCTAVE). Voir source | 37317841 | 10.1177/13524585231175284 | Multiple sclerosis (Houndmills, Basingstoke, England) | |
| Real-world COVID-19 immunity in multiple sclerosis (CoVaR-MS): A longitudinal follow up study. Voir source | 41518821 | 10.1016/j.msard.2025.106947 | Multiple sclerosis and related disorders | |
| Natalizumab is associated with improved relapse outcomes and lower healthcare utilization versus ocrelizumab in treatment-naïve people with multiple sclerosis. Voir source | 42323726 | 10.1080/13696998.2026.2681352 | Journal of medical economics | |
| Urinary tract infections, urosepsis, and multiple sclerosis disease modifying therapies: a disproportionality analysis of the FDA Adverse Event Reporting System. Voir source | 42435648 | 10.1016/j.msard.2026.107351 | Multiple sclerosis and related disorders | |
| The Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis. Voir source | 42462178 | 10.1212/NXI.0000000000200621 | Neurology(R) neuroimmunology & neuroinflammation | |
| Real-world pharmacovigilance analysis of the association between multiple sclerosis disease-modifying therapies and intervertebral disc herniation. Voir source | 42440544 | 10.3389/fphar.2026.1877458 | Frontiers in pharmacology | |
| The impact of age on efficacy and safety of disease modifying treatment-insights from the Austrian Multiple Sclerosis Treatment Registry. Voir source | 42283727 | 10.1007/s00415-026-13885-z | Journal of neurology |
Sources officielles
liens de rechercheDernière mise à jour des données : 2014-09-05
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.