MSFrontier

ORION

A Multinational, Prospective, Observational Study to Describe Multiple Sclerosis (MS) Patients Treated With Tolebrutinib as Per Approved Local Label in a Real-world Setting
RecruitingMS (type not specified)NCT07898371

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Socio-demographic Characteristics

    Baseline

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

    Baseline

    Disability progression

  • Disease History: EDSS Progression in Past 12 Months

    Baseline

    Disability progression

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

    Baseline

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

    Baseline

  • Disease History: Time Since Most Recent Clinical Relapse

    Baseline

    Relapses

  • Disease History: Number and Type of Previous MS Treatments

    Baseline

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

    Baseline

  • Disease History: Number of Participants with Comorbidities

    Baseline

  • Disease History: Number of Participants with Medical History

    Baseline

  • Disease History: Number of Participants with Concomitant Medication

    Baseline

  • Magnetic Resonance Imaging Data

    Baseline

    MRI lesions

Other measures (17)

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

    Baseline up to 36 months

    Disability progression

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

    Baseline up to 36 months

    Disability progressionWalking and mobility

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

    Baseline up to 36 months

    Disability progressionArm and hand function

  • Change from Baseline in Symbol Digit Modalities Test (SDMT)

    Baseline up to 36 months

    Thinking and memory

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

    Baseline up to 36 months

    Quality of life (reported by participants)

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

    Baseline up to 36 months

    PainQuality of life (reported by participants)

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

    Baseline up to 36 months

    Bladder, bowel and sexual functionQuality of life (reported by participants)

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

    Baseline up to 36 months

    Walking and mobilityQuality of life (reported by participants)

  • Change from Baseline in Modified Fatigue Impact Scale (MFIS)

    Baseline up to 36 months

    Thinking and memoryFatigueQuality of life (reported by participants)

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

    Baseline up to 36 months

    Thinking and memoryFatigue

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Willing to participate with the ability to consent and sign an Informed Consent Form (ICF). * Treatment decision according to approved local label. Retrospective inclusion of patients who had initiated tolebrutinib up to a maximum of 4 weeks prior to signing the ICF is allowed. Exclusion Criteria: * Participation in tolebrutinib long-term safety (LTS) study or any prior tolebrutinib study; experience with any other Bruton's Tyrosine Kinase (BTK) inhibitors. * Current or planned/pending participation in a clinical study. * Inability to comply with the study protocol The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This study aims to assess the real-world treatment patterns, data from patient reported outcomes, the effectiveness profile of tolebrutinib, and health care utilization data in routine practice. The decision to initiate tolebrutinib treatment is made by the treating neurologist as part of standard of care. Consideration and option of participation in the study will only be done once the treatment decision has been made, independent of study participation. Only upon signing the informed consent form (ICF) will the patient be enrolled in the study. The patient's participation in the study will not influence the MS treatment. Total study duration of study is 5 years per country comprising an approximately 24-months of enrollment period followed by a 36-month individual observational period.

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History

    1. Started

      Oct 2026

    2. Main results due

      Sept 2031

    3. Finished

      Oct 2031

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