Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
318 participants
OBSERVATIONAL
2021-10-12
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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On Natalizumab: Switcher IV to SC Cohort
Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
Natalizumab
Administered as specified in the treatment arm.
Natalizumab-Naive IV Cohort
Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months
Natalizumab
Administered as specified in the treatment arm.
Natalizumab-Naive SC Cohort
Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
Natalizumab
Administered as specified in the treatment arm.
Interventions
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Natalizumab
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC
Exclusion Criteria
* Contraindication to natalizumab treatment according to natalizumab SmPC
* Concomitant treatment with other drugs for treating RRMS
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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 im Odenwald, , 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, , 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 am Inn, , 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
Countries
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References
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Gold R, Schmidt S, Deisenhammer F, Motte J, Richter N, Taipale K, Salmen HC, Bohland C, Schirduan K. Real-world evidence and patient preference for subcutaneous versus intravenous natalizumab in the treatment of relapsing-remitting multiple sclerosis - initial results from the observational SISTER study. Ther Adv Neurol Disord. 2024 Apr 13;17:17562864241241382. doi: 10.1177/17562864241241382. eCollection 2024.
Other Identifiers
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DE-TYS-11923
Identifier Type: -
Identifier Source: org_study_id
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