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Completed

NCT Number: NCT06127095

A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments

The primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Biogen

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants diagnosed with RRMS and followed by a neurologist in France.

Exclusion criteria

  • Lack of literacy

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale

    Time frame: Day 1

    A Likert scale is a rating scale used to measure opinions, attitudes, or behaviors. This 7-pointer scale consists of a statement or a question, followed by a series of five or seven answer statements. Respondents choose the option that best corresponds with how they feel about the statement or question. The options include: strongly agree, agree, somewhat agree, neutral, somewhat disagree, disagree to strongly disagree.

Secondary outcomes

  1. Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions

    Time frame: Day 1

  2. Number of Participants With Perceived Decision-making Process Assessed by Likert's Scale

    Time frame: Day 1

    A Likert scale is a rating scale used to measure opinions, attitudes, or behaviors. This 7-pointer scale consists of a statement or a question, followed by a series of five or seven answer statements. Respondents choose the option that best corresponds with how they feel about the statement or question. The options include: strongly agree, agree, somewhat agree, neutral, somewhat disagree, disagree to strongly disagree.

  3. Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)

    Time frame: Day 1

  4. Number of Participants Characterized by Multiple Sclerosis (MS) Types

    Time frame: Day 1

  5. Number of Participants Characterized by MS Duration

    Time frame: Day 1

  6. Number of Participants Characterized by Current Disease Modifying Treatment (DMT)

    Time frame: Day 1

  7. Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score

    Time frame: Day 1

    The MusiQoL is a self-administered questionnaire consisting of 31 items describing nine dimensions of health-related QoL: activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system. All items are scored based on frequency/extent of an event on a five-point scale ranging from 1 (never/not at all) to 5 (always/very much). Total score is obtained by linearly transforming and standardizing on a 0-100 scale. Higher scores indicate a better QOL.

  8. Mean Fatigue Severity Scale (FSS) Score

    Time frame: Day 1

    FSS is designed to differentiate fatigue from clinical depression. FSS is a 9-item questionnaire that requires the participant to rate their own level of fatigue on a scale of 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 9 to 63. A higher total score indicates greater fatigue severity and impairment.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

New perSEPtion. New Patient's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based RRMS Treatments.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Dec 18, 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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