RecruitingNCT06267781

RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies

Biomarkers of Disease PROgression and Myeloid Profiling in Patients With Relapsing Remitting Multiple Sclerosis Treated With Autologous Hematopoietic Stem Cell TRANSPLANTation and Second Line Therapies.


Sponsor

IRCCS San Raffaele

Enrollment

30 participants

Start Date

Sep 2, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years;
  • Signed written informed consent;
  • A diagnosis of RRMS according to the 2017 Revisions of the McDonald Criteria;
  • High clinical and magnetic resonance imaging (MRI) inflammatory disease activity (at least 2 clinical relapses, or one clinical relapse with gadolinium (Gd)- enhancing or new T2 MRI lesions at a separate time point, in the previous 12 months)
  • Patients referred for pharmacological treatment with aHSCT, alemtuzumab or ocrelizumab /ofatumumab, according to clinical practice following the Italian pharmacological regulatory agency (AIFA) criteria and guidelines and recommendations from the European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE);

Exclusion Criteria2

  • Diagnosis of PPMS or SPMS according to the 2017 McDonald criteria
  • Known intolerances/allergies to the active substance or the excipients contained in the DMT and/or contraindications according to product information

Locations(1)

IRCCS San Raffaele

Milan, Italy

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NCT06267781


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