A Study for Tysabri Participant Preference

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Description

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.

Study Overview

Start Date
October 12, 2021
Completion Date
June 30, 2024
Enrollment
500
Date Posted
March 31, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
Augsburg, Germany

Praxis Dr. Schöll
Bad Homburg, Germany

Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany

Neurologische Praxis Dr. med. Boris-Alexander Kallmann
Bamberg, Germany

Marianne-Strauß-Klinik Starnberg
Berg, Germany

Neurologie am Mexikoplatz
Berlin, Germany

Neurologie im Tempelhofer Hafen Berlin
Berlin, Germany

Neurologisches Facharztzentrum Dr. Masri & Kollegen
Berlin, Germany

NFZB Neurologisches Facharztzentrum Berlin
Berlin, Germany

Praxis für Neurologie/Dr. med. Martin Delf
Berlin, Germany

Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Praxis Dres. Kausch/Lippert
Bogen, Germany

Neurologische Studiengesellschaft Bonn GbR
Bonn, Germany

MVZ Daun GmbH
Daun, Germany

Neurologie Dillingen
Dillingen, Germany

Gemeinschaftspraxis für Neurologie
Düsseldorf, Germany

Praxis Dr. Hartmann
Eltville, Germany

Neuro Centrum science GmbH
Erbach, Germany

Universitätsklinikum Erlangen, Neurolische Klinik
Erlangen, Germany

med.ring GmbH
Essen, Germany

NeuroDot GmbH
Grevenbroich, Germany

GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
Hagen, Germany

Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
Halle (Saale), Germany

Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
Jena, Germany

Praxis Dr. Fischer
Lappersdorf, Germany

Neurokomm - Gesellschaft für Studien und Kommunikation
Mannheim, Germany

NPS Neurologisch Psychiatrische Studiengesellschaft
Mannheim, Germany

GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
Minden, Germany

Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
Mistelbach, Germany

Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
Mittweida, Germany

Amperklinikum München Haar
München, Germany

CODAST
München, Germany

Neurologie Neu-Ulm
Neu-Ulm, Germany

Bergmann.Consult
Neuburg, Germany

Neurozentrum Prien
Prien am Chiemsee, Germany

EMSA
Singen, Germany

NeuroSinsheim
Sinsheim, Germany

Nervenfachärztliche GP
Ulm, Germany

Neuropraxis München Süd
Unterhaching, Germany

Praxis Dr. Krause
Wolfratshausen, Germany

Eligibility

Study Population
Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.
Minimum Age (years)
18
Eligibility Criteria
Key Inclusion Criteria:

Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC

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 defined Inclusion/Exclusion criteria may apply.

Study Contact Info

Study Contact Name
US Biogen Clinical Trial Center; Global Biogen Clinical Trial Center
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05304520