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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Study Type: Observational
• Enrollment (Actual): 474

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Biogen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with RRMS who have been prescribed natalizumab (Tysabri®) whether injected IV or SC, ocrelizumab (Ocrevus®), or ofatumumab (Kesimpta®) under standard clinical care for more than 6 months.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with RRMS; Participants who receive natalizumab intravenously (IV) or subcutaneously (SC) or ocrelizumab, or ofatumumab, as per the standard local prescribing procedures will be enrolled to collect data. Participants will complete an online one-shot questionnaire combining closed and open-ended questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Day 1
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 Multiple Sclerosis (MS) Types		Day 1
Number of Participants Characterized by MS Duration		Day 1
Number of Participants Characterized by Current Disease Modifying Treatment (DMT)		Day 1
Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score	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.	Day 1
Mean Fatigue Severity Scale (FSS) Score	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.	Day 1

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Actual): November 28, 2024
• Study Completion (Actual): November 28, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: FR-TYS-12186; 2023-A01349-36 (Other Identifier: CPP Nord Ouest)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No