Clinical trial NCT05304520: A Study for Tysabri Participant Preference
Official title: SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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: 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.

Primary outcomes:
measure: Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
timeFrame: Month 6
measure: Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Number of Participants Positive for Anti-Natalizumab-Antibody
timeFrame: Baseline, Month 6 and 12
measure: Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
timeFrame: Baseline, Month 6 and 12
measure: Annual Relapse Rate
timeFrame: Baseline, Months 3, 6, 9, and 12
measure: Time to Relapse
timeFrame: Baseline, Months 3, 6, 9, and 12
measure: Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab
timeFrame: Baseline, Months 3, 6, 9, and 12
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
city: Bad Homburg
country: Germany
facility: Praxis Dr. Schöll
city: Bad Mergentheim
country: Germany
facility: Caritas Krankenhaus Bad Mergentheim
city: Bamberg
country: Germany
facility: Neurologische Praxis Dr. med. Boris-Alexander Kallmann
city: Berg
country: Germany
facility: Marianne-Strauß-Klinik Starnberg
city: Berlin
country: Germany
facility: Neurologie am Mexikoplatz
city: Berlin
country: Germany
facility: Neurologie im Tempelhofer Hafen Berlin
city: Berlin
country: Germany
facility: Neurologisches Facharztzentrum Dr. Masri & Kollegen
city: Berlin
country: Germany
facility: NFZB Neurologisches Facharztzentrum Berlin
city: Berlin
country: Germany
facility: Praxis für Neurologie/Dr. med. Martin Delf
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Bogen
country: Germany
facility: Praxis Dres. Kausch/Lippert
city: Bonn
country: Germany
facility: Neurologische Studiengesellschaft Bonn GbR
city: Daun
country: Germany
facility: MVZ Daun GmbH
city: Dillingen
country: Germany
facility: Neurologie Dillingen
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Eltville
country: Germany
facility: Praxis Dr. Hartmann
city: Erbach
country: Germany
facility: Neuro Centrum science GmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Neurolische Klinik
city: Essen
country: Germany
facility: med.ring GmbH
city: Grevenbroich
country: Germany
facility: NeuroDot GmbH
city: Hagen
country: Germany
facility: GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
city: Lappersdorf
country: Germany
facility: Praxis Dr. Fischer
city: Mannheim
country: Germany
facility: Neurokomm - Gesellschaft für Studien und Kommunikation
city: Mannheim
country: Germany
facility: NPS Neurologisch Psychiatrische Studiengesellschaft
city: Minden
country: Germany
facility: GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
city: Mistelbach
country: Germany
facility: Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
city: Mittweida
country: Germany
facility: Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
city: München
country: Germany
facility: Amperklinikum München Haar
city: München
country: Germany
facility: CODAST
city: Neu-Ulm
country: Germany
facility: Neurologie Neu-Ulm
city: Neuburg
country: Germany
facility: Bergmann.Consult
city: Prien am Chiemsee
country: Germany
facility: Neurozentrum Prien
city: Singen
country: Germany
facility: EMSA
city: Sinsheim
country: Germany
facility: NeuroSinsheim
city: Ulm
country: Germany
facility: Nervenfachärztliche GP
city: Unterhaching
country: Germany
facility: Neuropraxis München Süd
city: Wolfratshausen
country: Germany
facility: Praxis Dr. Krause
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: