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NCT05304520Completed

A Study for Tysabri Participant Preference

SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World

Source: ClinicalTrials.gov · Last updated 17 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
318 (actual)
First submitted
22 Mar 2022
Start date
12 Oct 2021
Primary completion date
30 Apr 2024
Lead sponsor
Biogen
NCT number
NCT05304520

What you commit to

  • Study type: Observational
  • Participants enrolled: 318
  • From 12 Oct 2021 to the primary completion date, 30 Apr 2024
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant treatment with other drugs for treating RRMS

Other

  • Progressive forms of MS
  • Contraindication to natalizumab treatment according to natalizumab SmPC
  • Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
Coordinator of this site? Confirm its status
AugsburgGermanyUnknown status
Praxis Dr. Schöll
Coordinator of this site? Confirm its status
Bad HomburgGermanyUnknown status
Caritas-Krankenhaus Bad Mergentheim
Coordinator of this site? Confirm its status
Bad MergentheimGermanyUnknown status
Neurologische Praxis Dr. med. Boris-Alexander Kallmann
Coordinator of this site? Confirm its status
BambergGermanyUnknown status
Marianne-Strauß-Klinik Starnberg
Coordinator of this site? Confirm its status
BergGermanyUnknown status
NFZB Neurologisches Facharztzentrum Berlin
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BerlinGermanyUnknown status
Neurologie im Tempelhofer Hafen Berlin
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Neurologie am Mexikoplatz
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Neurologisches Facharztzentrum Dr. Masri & Kollegen
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Praxis für Neurologie/Dr. med. Martin Delf
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Katholisches Klinikum Bochum gGmbH
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BochumGermanyUnknown status
Praxis Dres. Kausch/Lippert
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BogenGermanyUnknown status
Neurologische Studiengesellschaft Bonn GbR
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BonnGermanyUnknown status
MVZ Daun GmbH
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DaunGermanyUnknown status
Neurologie Dillingen
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DillingenGermanyUnknown status
Gemeinschaftspraxis für Neurologie
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DüsseldorfGermanyUnknown status
Praxis Dr. Hartmann
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EltvilleGermanyUnknown status
Neuro Centrum Science GmbH
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Erbach im OdenwaldGermanyUnknown status
Universitätsklinikum Erlangen, Neurolische Klinik
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ErlangenGermanyUnknown status
med.ring GmbH
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EssenGermanyUnknown status
NeuroDot GmbH
Coordinator of this site? Confirm its status
GrevenbroichGermanyUnknown status
GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
Coordinator of this site? Confirm its status
HagenGermanyUnknown status
Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
Coordinator of this site? Confirm its status
JenaGermanyUnknown status
Praxis Dr. Fischer
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LappersdorfGermanyUnknown status
NPS Neurologisch Psychiatrische Studiengesellschaft
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MannheimGermanyUnknown status
Neurokomm - Gesellschaft für Studien und Kommunikation
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MannheimGermanyUnknown status
GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
Coordinator of this site? Confirm its status
MindenGermanyUnknown status
Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
Coordinator of this site? Confirm its status
MistelbachGermanyUnknown status
Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
Coordinator of this site? Confirm its status
MittweidaGermanyUnknown status
Amperklinikum München Haar
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MünchenGermanyUnknown status
CODAST
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MünchenGermanyUnknown status
Bergmann.Consult
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Neuburg am InnGermanyUnknown status
Neurologie Neu-Ulm
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Neu-UlmGermanyUnknown status
Neurozentrum Prien
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Prien am ChiemseeGermanyUnknown status
EMSA
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SingenGermanyUnknown status
NeuroSinsheim
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SinsheimGermanyUnknown status
Nervenfachärztliche GP
Coordinator of this site? Confirm its status
UlmGermanyUnknown status
Neuropraxis München Süd
Coordinator of this site? Confirm its status
UnterhachingGermanyUnknown status
Praxis Dr. Krause
Coordinator of this site? Confirm its status
WolfratshausenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.