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NCT Number: NCT05304520

A Study for Tysabri Participant Preference

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.

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Key information

Conditions

Relapsing-remitting Multiple Sclerosis (rrMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

Administered as specified in the treatment arm.

Primary outcomes

  1. 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?".

  2. 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?".

Secondary outcomes

  1. Number of Participants Positive for Anti-Natalizumab-Antibody

    Time frame: Baseline, Month 6 and 12

  2. Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody

    Time frame: Baseline, Month 6 and 12

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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