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

NCT06127095 | Completed

• 2 other identifiers: FR-TYS-121862023-A01349-36
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Lack of literacy

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Biogen

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 24, 2023
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)