A Study for Tysabri Participant Preference

May 16, 2024 updated by: Biogen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Positive for Anti-Natalizumab-Antibody
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Annual Relapse Rate
Time Frame: Baseline, Months 3, 6, 9, and 12
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
Time Frame: Baseline, Months 3, 6, 9, and 12
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
Time Frame: Baseline, Months 3, 6, 9, and 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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