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

NCT ID: NCT06127095

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

474 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-24

Study Completion Date

2024-11-28

Brief Summary

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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

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Lack of literacy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Biogen

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2023-A01349-36

Identifier Type: OTHER

Identifier Source: secondary_id

FR-TYS-12186

Identifier Type: -

Identifier Source: org_study_id