A Study for Tysabri Participant Preference

Last updated: May 16, 2024
Sponsor: Biogen
Overall Status: Completed

Phase

N/A

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

Natalizumab

Clinical Study ID

NCT05304520
DE-TYS-11923
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiatingnatalizumab treatment is indicated based on current summary of productcharacteristics (SmPC)

  • In RRMS participants who are already on natalizumab therapy, continued treatmentmust be indicated based on current SmPC

Exclusion

Key Exclusion Criteria:

  • Progressive forms of MS

  • Contraindication to natalizumab treatment according to natalizumab SmPC

  • Concomitant treatment with other drugs for treating RRMS

  • Participation in any interventional clinical trial NOTE: Other protocol definedInclusion/Exclusion criteria may apply.

Study Design

Total Participants: 318
Treatment Group(s): 1
Primary Treatment: Natalizumab
Phase:
Study Start date:
October 12, 2021
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid

    Augsburg,
    Germany

    Site Not Available

  • Praxis Dr. Schöll

    Bad Homburg,
    Germany

    Site Not Available

  • Caritas Krankenhaus Bad Mergentheim

    Bad Mergentheim,
    Germany

    Site Not Available

  • Neurologische Praxis Dr. med. Boris-Alexander Kallmann

    Bamberg,
    Germany

    Site Not Available

  • Marianne-Strauß-Klinik Starnberg

    Berg,
    Germany

    Site Not Available

  • NFZB Neurologisches Facharztzentrum Berlin

    Berlin,
    Germany

    Site Not Available

  • Neurologie am Mexikoplatz

    Berlin,
    Germany

    Site Not Available

  • Neurologie im Tempelhofer Hafen Berlin

    Berlin,
    Germany

    Site Not Available

  • Neurologisches Facharztzentrum Dr. Masri & Kollegen

    Berlin,
    Germany

    Site Not Available

  • Praxis für Neurologie/Dr. med. Martin Delf

    Berlin,
    Germany

    Site Not Available

  • Katholisches Klinikum Bochum gGmbH

    Bochum,
    Germany

    Site Not Available

  • Praxis Dres. Kausch/Lippert

    Bogen,
    Germany

    Site Not Available

  • Neurologische Studiengesellschaft Bonn GbR

    Bonn,
    Germany

    Site Not Available

  • MVZ Daun GmbH

    Daun,
    Germany

    Site Not Available

  • Neurologie Dillingen

    Dillingen,
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Düsseldorf,
    Germany

    Site Not Available

  • Praxis Dr. Hartmann

    Eltville,
    Germany

    Site Not Available

  • Neuro Centrum science GmbH

    Erbach,
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen, Neurolische Klinik

    Erlangen,
    Germany

    Site Not Available

  • med.ring GmbH

    Essen,
    Germany

    Site Not Available

  • NeuroDot GmbH

    Grevenbroich,
    Germany

    Site Not Available

  • GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros

    Hagen,
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie

    Halle (Saale),
    Germany

    Site Not Available

  • Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie

    Jena,
    Germany

    Site Not Available

  • Praxis Dr. Fischer

    Lappersdorf,
    Germany

    Site Not Available

  • NPS Neurologisch Psychiatrische Studiengesellschaft

    Mannheim,
    Germany

    Site Not Available

  • Neurokomm - Gesellschaft für Studien und Kommunikation

    Mannheim,
    Germany

    Site Not Available

  • GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker

    Minden,
    Germany

    Site Not Available

  • Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie

    Mistelbach,
    Germany

    Site Not Available

  • Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida

    Mittweida,
    Germany

    Site Not Available

  • Amperklinikum München Haar

    München,
    Germany

    Site Not Available

  • CODAST

    München,
    Germany

    Site Not Available

  • Neurologie Neu-Ulm

    Neu-Ulm,
    Germany

    Site Not Available

  • Bergmann.Consult

    Neuburg,
    Germany

    Site Not Available

  • Neurozentrum Prien

    Prien am Chiemsee,
    Germany

    Site Not Available

  • EMSA

    Singen,
    Germany

    Site Not Available

  • NeuroSinsheim

    Sinsheim,
    Germany

    Site Not Available

  • Nervenfachärztliche GP

    Ulm,
    Germany

    Site Not Available

  • Neuropraxis München Süd

    Unterhaching,
    Germany

    Site Not Available

  • Praxis Dr. Krause

    Wolfratshausen,
    Germany

    Site Not Available

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