A Study for Tysabri Participant Preference
SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
1 other identifier
observational
318
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2021
CompletedFirst Submitted
Initial submission to the registry
March 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 17, 2024
May 1, 2024
2.6 years
March 22, 2022
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Month 6
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Month 12
Secondary Outcomes (5)
Number of Participants Positive for Anti-Natalizumab-Antibody
Baseline, Month 6 and 12
Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
Baseline, Month 6 and 12
Annual Relapse Rate
Baseline, Months 3, 6, 9, and 12
Time to Relapse
Baseline, Months 3, 6, 9, and 12
Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab
Baseline, Months 3, 6, 9, and 12
Study Arms (3)
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.
Interventions
Administered as specified in the treatment arm.
Eligibility Criteria
Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.
You may qualify if:
- 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
You may not qualify if:
- Progressive forms of MS
- Contraindication to natalizumab treatment according to natalizumab SmPC
- Concomitant treatment with other drugs for treating RRMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (40)
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
Related Publications (1)
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.
PMID: 38616781DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2022
First Posted
March 31, 2022
Study Start
October 12, 2021
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/