A Study to Describe Multiple Sclerosis Patients Treated With Tolebrutinib as Per Label in a Real-world Setting

Browse trials for

• Multiple Sclerosis 3,264

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Lead sponsor

Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.

Study population

Groups and cohorts

• Tolebrutinib

  Drug: Tolebrutinib

Interventions

• DrugTolebrutinib

  This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcomes

1. Socio-demographic Characteristics

   Number and percentage of participants with socio-demographic characteristics including age, gender, occupational status will be collected.

   Time frame: Baseline

2. Disease History: Most Recent Disability Status Scale (EDSS) score

   Disease history including EDSS score will be collected. The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5.

   Time frame: Baseline

3. Disease History: EDSS Progression in Past 12 Months

   Disease history including EDSS progression in past 12 Months will be collected. The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5.

   Time frame: Baseline

4. Disease History: Time Since Relapsing-Remitting Multiple Sclerosis (RRMS) Symptom Onset

   Disease history including time (in years) since RRMS symptom onset will be collected.

   Time frame: Baseline

5. Disease History: Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis

   Disease history including time (in years) since SPMS diagnosis will be collected.

   Time frame: Baseline

6. Disease History: Time Since Most Recent Clinical Relapse

   Disease history including time (in years) since most recent clinical relapse will be collected.

   Time frame: Baseline

7. Disease History: Number and Type of Previous MS Treatments

   Disease history including number and type of previous MS treatments will be collected.

   Time frame: Baseline

8. Disease History: Number and Type of Prior and Current Disease Modifying Therapies (DMTs)

   Disease history including number and type prior and current DMTs will be collected.

   Time frame: Baseline

9. Disease History: Number of Participants with Comorbidities

   Disease history including comorbidities will be collected.

   Time frame: Baseline

10. Disease History: Number of Participants with Medical History

    Disease history including medical history will be collected.

    Time frame: Baseline

11. Disease History: Number of Participants with Concomitant Medication

    Disease history including concomitant medication will be collected.

    Time frame: Baseline

12. Magnetic Resonance Imaging Data

    MRI data will be collected.

    Time frame: Baseline

Secondary outcomes

1. Change from Baseline in Individual Expanded Disability Status Scale (EDSS) Score

   The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5.

   Time frame: Baseline up to 36 months

2. Change from Baseline in Timed 25-Foot Walk Test (T25FW)

   The mean walk time will be used for assessment of the patient's walking ability. An increase of more than 20 percent (%) from the baseline in the T25-FW test is considered meaningful worsening.

   Time frame: Baseline up to 36 months

3. Change from Baseline in 9-Hole Peg Test (9-HPT)

   Time to complete the 9-HPT will be used to assess a participant's manual dexterity and fine motor skills. The mean time to test completion will serve for assessment of the patient's hand dexterity. An increase of more than 20 percent (%) from the baseline in the 9-HPT is considered meaningful worsening.

   Time frame: Baseline up to 36 months

4. Change from Baseline in Symbol Digit Modalities Test (SDMT)

   The SDMT is used to assess visual scanning, tracking and motor speed, and has been designed to detect cognitive impairment. The SDMT involves a simple substitution task that normal children and adults can easily perform. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures.

   Time frame: Baseline up to 36 months

5. Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)

   The MSIS-29 is a scale that measures the physical (20 items) and psychological (9 items) impact of MS. Two summary scores (eg, the physical scale and the psychological scale) are calculated by summing up individual items in each scale and transforming the scores into a 0-100 scale. High scores indicate a higher impact of MS on the patient's physical and/or psychological health.

   Time frame: Baseline up to 36 months

6. Change from Baseline in Short Form Health Survey (SF-36) The

   The SF-36 is a 36-item questionnaire designed to measure health-related quality of life. It assesses eight domains of health, including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, and mental health.

   Time frame: Baseline up to 36 months

7. Change from Baseline in Multiple Sclerosis International Quality of Life (MuSIQoL)

   The MusiQoL questionnaire is a 31-item, MS-specific tool that measures quality of life from the patient's perspective. It covers nine domains-daily activities, psychological well-being, symptoms, relationships with friends and family, sentimental/sexual life, coping, and experiences of rejection-plus an overall index score. Items use a five-point scale, with higher scores reflecting better quality of life.

   Time frame: Baseline up to 36 months

8. Change from Baseline in Multiple Sclerosis Walking Scale (MSWS-12)

   The 12-item MSWS is a validated patient-reported measure of the impact of MS on the individual's walking ability. A low MSWS-12 score indicates minimal impact of MS on walking ability, reflecting better mobility and fewer limitations in daily activities. Conversely, a high MSWS-12 score indicates a greater impact of MS on walking reflecting more significant mobility impairment and increased difficulty performing walking-related tasks.

   Time frame: Baseline up to 36 months

9. Change from Baseline in Modified Fatigue Impact Scale (MFIS)

   The MFIS, 21-item questionnaire, is designed to evaluate how fatigue affects physical, cognitive, and psychosocial functioning. A lower MFIS score indicates that fatigue has minimal impact on a person's physical, cognitive, and psychosocial functioning. In contrast, a higher MFIS score reflects a greater impact of fatigue, suggesting more substantial interference with daily activities and overall quality of life.

   Time frame: Baseline up to 36 months

10. Change from Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)

    The FSMC is a 20-item questionnaire designed to assess both cognitive and motor fatigue, particularly in individuals with MS. Each item is rated on a 5-point Likert scale, ranging from "does not apply at all" to "applies completely," resulting in a total score between 20 (no fatigue) and 100 (severe fatigue).

    Time frame: Baseline up to 36 months

11. Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM)

    The 14-item TSQM is a tool to assess patient satisfaction with medication. The tool includes four domains: Effectiveness (3 items), Side Effects (5 items), Convenience (3 items), and Global Satisfaction (3 items). It uses 5- or 7-point Likert-type scales and Yes/No responses.

    Time frame: Baseline up to 36 months

12. Change from Baseline in Work Productivity and Activity Impairment - Multiple Sclerosis (WPAI-MS)

    The WPAI-MS questionnaire is a 6-item instrument to measure impairments over the past 7 days in both paid work and unpaid work due to one's health. Respondents are asked questions about work and activity impairment due to health problems.

    Time frame: Baseline up to 36 months

13. Change from Baseline in Chronic Treatment Acceptance Questionnaire (ACCEPT)

    The ACCEPT is a patient questionnaire with 25 items which evaluates the patient's acceptance of long-term treatment in real-life. Low scores indicate poor acceptance, moderate scores reflect a neutral stance, and high scores indicate strong acceptance.

    Time frame: Baseline up to 36 months

14. Change from Baseline in Patient Global Impression of Change (PGIC)

    The PGIC scale is administered at the end of the test-retest period and asks respondents to rate their symptom severity now/today compared to the beginning of the test-retest period. PGIC response options typically use a bi-directional response scale, eg, 5 to 7 options ranging from "Much better" to "Much worse" with "No change" at the midpoint. Lower scores indicate improvement, 4 indicates no change, and higher scores indicate worsening of the patient's condition.

    Time frame: Baseline up to 36 months

15. Change from Baseline in Patient Global Impression of Severity (PGIS)

    The PGIS Scale asks respondents to rate their symptom or disease severity at a given time, and it is administered at multiple timepoints, including the beginning and the end of the test-retest period. Response options, in the form of a unidirectional verbal rating scale (VRS), often range from "None" to "Very severe". Lower scores indicate mild or no symptoms, moderate scores indicate noticeable impact, and higher scores indicate severe or very severe symptoms.

    Time frame: Baseline up to 36 months

16. Change from Baseline in Health resource utilization questionnaire (HRUQ)

    The HRUQ is a PRO designed to capture patient-reported data on healthcare resource use, medication adherence, and work productivity over the past month, specifically in the context of MS management. Data collected from the HRUQ can be used to estimate healthcare utilization patterns, economic burden, and cost outcomes.

    Time frame: Baseline up to 36 months

17. Number of Participants with at Least one AE, SAE, AEs by Maximum Severity, AEs Leading to treatment Discontinuation and AESI

    An adverse event (AE) was defined as any untoward medical occurrence in a subject who received study drug and did not necessarily had a causal relationship with the study treatment. Serious AEs (SAEs): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. An adverse event of special interest (AESI) is an adverse event (serious or non-serious) of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication to the provider is required.

    Time frame: Baseline up to 36 months

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org