A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Registration Number
- NCT06127095
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
• Participants diagnosed with RRMS and followed by a neurologist in France.
• Lack of literacy
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale 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 Outcome Measures
Name Time Method Number of Participants Characterized by MS Duration Day 1 Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions Day 1 Number of Participants With Perceived Decision-making Process Assessed by Likert's Scale 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.
Number of Participants Characterized by Multiple Sclerosis (MS) Types Day 1 Mean Fatigue Severity Scale (FSS) Score 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.
Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL) Day 1 Number of Participants Characterized by Current Disease Modifying Treatment (DMT) Day 1 Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score 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.
Trial Locations
- Locations (1)
Biogen
🇺🇸Cambridge, Massachusetts, United States