A Study for Tysabri Participant Preference

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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)
• Intervention / Treatment: Drug: Natalizumab

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid
  • Bad Homburg, Germany
    • Praxis Dr. Schöll
  • Bad Mergentheim, Germany
    • Caritas Krankenhaus Bad Mergentheim
  • Bamberg, Germany
    • Neurologische Praxis Dr. med. Boris-Alexander Kallmann
  • Berg, Germany
    • Marianne-Strauß-Klinik Starnberg
  • Berlin, 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
  • Bochum, Germany
    • Katholisches Klinikum Bochum gGmbH
  • Bogen, Germany
    • Praxis Dres. Kausch/Lippert
  • Bonn, Germany
    • Neurologische Studiengesellschaft Bonn GbR
  • Daun, Germany
    • MVZ Daun GmbH
  • Dillingen, Germany
    • Neurologie Dillingen
  • Düsseldorf, Germany
    • Gemeinschaftspraxis für Neurologie
  • Eltville, Germany
    • Praxis Dr. Hartmann
  • Erbach, Germany
    • Neuro Centrum Science GmbH
  • Erlangen, Germany
    • Universitätsklinikum Erlangen, Neurolische Klinik
  • Essen, Germany
    • med.ring GmbH
  • Grevenbroich, Germany
    • NeuroDot GmbH
  • Hagen, Germany
    • GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros
  • Halle (Saale), Germany
    • Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie
  • Jena, Germany
    • Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie
  • Lappersdorf, Germany
    • Praxis Dr. Fischer
  • Mannheim, Germany
    • Neurokomm - Gesellschaft für Studien und Kommunikation
  • Mannheim, Germany
    • NPS Neurologisch Psychiatrische Studiengesellschaft
  • Minden, Germany
    • GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker
  • Mistelbach, Germany
    • Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie
  • Mittweida, Germany
    • Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida
  • München, Germany
    • Amperklinikum München Haar
  • München, Germany
    • CODAST
  • Neu-Ulm, Germany
    • Neurologie Neu-Ulm
  • Neuburg, Germany
    • Bergmann.Consult
  • Prien am Chiemsee, Germany
    • Neurozentrum Prien
  • Singen, Germany
    • EMSA
  • Sinsheim, Germany
    • NeuroSinsheim
  • Ulm, Germany
    • Nervenfachärztliche GP
  • Unterhaching, Germany
    • Neuropraxis München Süd
  • Wolfratshausen, Germany
    • Praxis Dr. Krause

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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	Drug: 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.	Drug: Natalizumab; Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.	Baseline, Months 3, 6, 9, and 12
Time to Relapse	An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings.	Baseline, Months 3, 6, 9, and 12
Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab	Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score >0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease.	Baseline, Months 3, 6, 9, and 12

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Natalizumab
• Other Study ID Numbers: DE-TYS-11923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No