A Study for Tysabri Participant Preference

Relapsing-Remitting Multiple Sclerosis (RRMS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304520
• Other study ID #: DE-TYS-11923
• Status: Completed
• Start date: October 12, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis (RRMS)

Intervention

Drug:
• Natalizumab
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Germany	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
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 (Saale)
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants Positive for Anti-Natalizumab-Antibody		Baseline, Month 6 and 12
Secondary	Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody		Baseline, Month 6 and 12
Secondary	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
Secondary	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
Secondary	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