Multiple Sclerosis, Relapsing-RemittingNCT06127095
A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- Type of treatment
- Injection or infusion
- How many people
- 474 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2023to 28 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants diagnosed with RRMS and followed by a neurologist in France.
Who cannot join
- Lack of literacy
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (8)
Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions
Measured: 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.
Measured: Day 1
Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)
Measured: Day 1
Number of Participants Characterized by Multiple Sclerosis (MS) Types
Measured: Day 1
Number of Participants Characterized by MS Duration
Measured: Day 1
Number of Participants Characterized by Current Disease Modifying Treatment (DMT)
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start24 Nov 2023
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127095
- Sponsor's protocol ID
- FR-TYS-12186
- Other IDs
- 2023-A01349-36
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New perSEPtion. New Patient's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based RRMS Treatments.
- ClinicalTrials.gov ID
- NCT06127095
- Acronym / sponsor ID
- FR-TYS-12186
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participants diagnosed with RRMS and followed by a neurologist in France.
Key exclusion criteria (2 listed)
- Lack of literacy
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale
Time frame: 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.
8 secondary outcomes
Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions
Time frame: Day 1
Number of Participants With Perceived Decision-making Process Assessed by Likert's Scale
Time frame: Day 1
Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)
Time frame: Day 1
Number of Participants Characterized by Multiple Sclerosis (MS) Types
Time frame: Day 1
Number of Participants Characterized by MS Duration
Time frame: Day 1
Number of Participants Characterized by Current Disease Modifying Treatment (DMT)
Time frame: Day 1
Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score
Time frame: Day 1
Mean Fatigue Severity Scale (FSS) Score
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.