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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127095
• Other study ID #: FR-TYS-12186
• Status: Recruiting
• Start date: November 24, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	Biogen	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions		Day 1
Secondary	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
Secondary	Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)		Day 1
Secondary	Number of Participants Characterized by Multiple Sclerosis (MS) Types		Day 1
Secondary	Number of Participants Characterized by MS Duration		Day 1
Secondary	Number of Participants Characterized by Current Disease Modifying Treatment (DMT)		Day 1
Secondary	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
Secondary	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