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

Status: Completed
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
Augsburg
Praxis Dr. Schöll
Bad Homburg
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim
Neurologische Praxis Dr. med. Boris-Alexander Kallmann
Bamberg
Marianne-Strauß-Klinik Starnberg
Berg
Neurologie am Mexikoplatz
Berlin
Neurologie im Tempelhofer Hafen Berlin
Berlin
Neurologisches Facharztzentrum Dr. Masri & Kollegen
Berlin
NFZB Neurologisches Facharztzentrum Berlin
Berlin
Praxis für Neurologie/Dr. med. Martin Delf
Berlin
Katholisches Klinikum Bochum gGmbH
Bochum
Praxis Dres. Kausch/Lippert
Bogen
Neurologische Studiengesellschaft Bonn GbR
Bonn
MVZ Daun GmbH
Daun
Neurologie Dillingen
Dillingen
Gemeinschaftspraxis für Neurologie
Düsseldorf
Praxis Dr. Hartmann
Eltville
Neuro Centrum science GmbH
Erbach Im Odenwald
Universitätsklinikum Erlangen, Neurolische Klinik
Erlangen
med.ring GmbH
Essen
NeuroDot GmbH
Grevenbroich
GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
Hagen
Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
Halle
Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
Jena
Praxis Dr. Fischer
Lappersdorf
Neurokomm - Gesellschaft für Studien und Kommunikation
Mannheim
NPS Neurologisch Psychiatrische Studiengesellschaft
Mannheim
GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
Minden
Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
Mistelbach
Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
Mittweida
Amperklinikum München Haar
München
CODAST
München
Neurologie Neu-Ulm
Neu-ulm
Bergmann.Consult
Neuburg Am Inn
Neurozentrum Prien
Prien Am Chiemsee
EMSA
Singen
NeuroSinsheim
Sinsheim
Nervenfachärztliche GP
Ulm
Neuropraxis München Süd
Unterhaching
Praxis Dr. Krause
Wolfratshausen
Time Frame
Start Date: 2021-10-12
Completion Date: 2024-04-30
Participants
Target number of participants: 318
Treatments
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-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-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.
Related Therapeutic Areas
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials