A Study for Tysabri Participant Preference

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)
• Interventions: Drug: Natalizumab

• Registration Number: NCT05304520
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natalizumab-Naive SC Cohort	Natalizumab	Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
On Natalizumab: Switcher IV to SC Cohort	Natalizumab	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	Natalizumab	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

Primary Outcome Measures

Name	Time	Method
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6	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?".
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12	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?".

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab	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.
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
Time to Relapse	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	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.

Trial Locations

Locations (40)

Katholisches Klinikum Bochum gGmbH; 🇩🇪 Bochum, Germany

Neurologie am Mexikoplatz; 🇩🇪 Berlin, Germany

Neurologie Neu-Ulm; 🇩🇪 Neu-Ulm, Germany

Neuro Centrum science GmbH; 🇩🇪 Erbach, Germany

NeuroDot GmbH; 🇩🇪 Grevenbroich, Germany

Neurologisches Facharztzentrum Dr. Masri & Kollegen; 🇩🇪 Berlin, Germany

Neuropraxis München Süd; 🇩🇪 Unterhaching, Germany

Nervenfachärztliche GP; 🇩🇪 Ulm, Germany

EMSA; 🇩🇪 Singen, Germany

Praxis Dr. Krause; 🇩🇪 Wolfratshausen, Germany

Caritas Krankenhaus Bad Mergentheim; 🇩🇪 Bad Mergentheim, Germany

NeuroSinsheim; 🇩🇪 Sinsheim, Germany

Gemeinschaftspraxis für Neurologie; 🇩🇪 Düsseldorf, Germany

med.ring GmbH; 🇩🇪 Essen, Germany

Praxis Dr. Schöll; 🇩🇪 Bad Homburg, Germany

Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid; 🇩🇪 Augsburg, Germany

Marianne-Strauß-Klinik Starnberg; 🇩🇪 Berg, Germany

Neurologische Praxis Dr. med. Boris-Alexander Kallmann; 🇩🇪 Bamberg, Germany

NFZB Neurologisches Facharztzentrum Berlin; 🇩🇪 Berlin, Germany

Neurologie im Tempelhofer Hafen Berlin; 🇩🇪 Berlin, Germany

Praxis für Neurologie/Dr. med. Martin Delf; 🇩🇪 Berlin, Germany

Praxis Dres. Kausch/Lippert; 🇩🇪 Bogen, Germany

Neurologische Studiengesellschaft Bonn GbR; 🇩🇪 Bonn, Germany

MVZ Daun GmbH; 🇩🇪 Daun, Germany

Neurologie Dillingen; 🇩🇪 Dillingen, Germany

Universitätsklinikum Erlangen, Neurolische Klinik; 🇩🇪 Erlangen, Germany

Praxis Dr. Hartmann; 🇩🇪 Eltville, Germany

Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie; 🇩🇪 Jena, Germany

GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros; 🇩🇪 Hagen, Germany

NPS Neurologisch Psychiatrische Studiengesellschaft; 🇩🇪 Mannheim, Germany

Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie; 🇩🇪 Halle (Saale), Germany

Praxis Dr. Fischer; 🇩🇪 Lappersdorf, Germany

Neurokomm - Gesellschaft für Studien und Kommunikation; 🇩🇪 Mannheim, Germany

GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. Birgit Erker; 🇩🇪 Minden, Germany

Hygieia Pharmakologisches Studienzentrum Chemnitz GmbH, Außenstelle Mittweida; 🇩🇪 Mittweida, Germany

Neurozentrum Prien; 🇩🇪 Prien am Chiemsee, Germany

Bergmann.Consult; 🇩🇪 Neuburg, Germany

Landesklinkum Mistelbach-Gänserndorf, Abteilung Neurologie; 🇩🇪 Mistelbach, Germany

Amperklinikum München Haar; 🇩🇪 München, Germany

CODAST; 🇩🇪 München, Germany