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A Study for Tysabri Participant Preference | Clinical Trials | Clareo Health

COMPLETED

A Study for Tysabri Participant Preference

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

NCT05304520•Biogen

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•Progressive forms of MS
•Contraindication to natalizumab treatment according to natalizumab SmPC
•Concomitant treatment with other drugs for treating RRMS

Locations (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

Key Dates

Start Date

October 12, 2021

Primary Completion Date

April 30, 2024

Completion Date

April 30, 2024

Last Updated

May 17, 2024

Enrollment

318

ACTUAL participants

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Natalizumab

DRUG

Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

NCT02881567

Relapsing-Remitting Multiple Sclerosis (RRMS)

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WITHDRAWNPHASE4

Brimonidine Tartrate for the Treatment of Injection Related Erythema

NCT02568111

Relapsing-Remitting Multiple Sclerosis (RRMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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