PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis

Korábbi kezelés

• Patients exposed to Mitoxantrone, Alemtuzumab, or Cladribine within the 3 years prior to inclusion.
• Patients exposed to Ocrelizumab or Rituximab within the 18 months prior to inclusion.
• Patients exposed to Ofatumumab within the 12 months prior to inclusion.
• Patients receiving high-efficacy disease-modifying therapy [Natalizumab; Ofatumumab; Alemtuzumab; Cladribine; Mitoxantrone; Ocrelizumab], or Rituximab, with the exception of S1P receptor modulators.
• Patients receiving Mycophenolate mofetil, azathioprine, cyclophosphamide (Endoxan), or having undergone stem cell transplantation.
• Patients who have participated in a therapeutic trial within the 24 months prior to inclusion.

Más betegség

• Patients with current or past history of other autoimmune diseases.
• Patients with uncontrolled disease, other than active MS.

Egyéb

• Patients with a progressive form of multiple sclerosis (primary or secondary).
• Patients participating in another clinical trial, whether therapeutic or not, that could interfere with the objectives of the study.
• Pregnant or breastfeeding women, or those planning pregnancy during the study.
• Patients under legal protection (guardianship, curatorship, or other protective measures).

• Men and women aged >18 and ≤50 years.
• Patients with relapsing-remitting multiple sclerosis (RRMS) according to the McDonald 2024 criteria.
• Patients for whom a change in therapeutic management is being considered due to:
  • intolerance to treatment or personal preference in the absence of inflammatory activity, whether patients are:
  • on a moderately effective disease-modifying therapy [Interferon beta; Glatiramer acetate; Teriflunomide; Dimethyl fumarate; Diroximel fumarate] for at least 12 months without interruption
  • on anti-S1P therapy [Fingolimod; Ponesimod] for at least 12 months without interruption or
  • recent inflammatory activity (relapse or at least one T1 Gd+ lesion or one new T2 lesion) reported or observed at inclusion, whether patients are:
  • treatment-naïve
  • on a moderately effective disease-modifying therapy for at least 6 months or on anti-S1P therapy for at least 6 months
  • untreated for at least one year
• Patients with MRI follow-up including at least one 3D brain FLAIR sequence and a T1 Gd+ sequence in the case of a re-baseline brain MRI within the past 6 months.
• Patients whose MRI scans are available for download on the day of consultation.
• Patients affiliated with or beneficiaries of a social security system.
• Patients able to provide written informed consent. For women of childbearing potential, use of an effective method of contraception throughout the study in accordance with the recommendations of the Clinical Trials Coordination Group