Investigating the effects of therapies on multiple sclerosis progression after bone marrow transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how highly effective therapies can prevent disease progression in individuals with relapsing-remitting multiple sclerosis (RRMS) by analyzing the peripheral myeloid landscape. It focuses on the impact of disease-modifying therapies (DMTs) on preventing the transition to secondary progressive multiple sclerosis (SPMS) and understanding the underlying mechanisms of disease progression. The study will evaluate the effects of myeloablative autologous hematopoietic stem cell transplantation (aHSCT) compared to other DMTs like ocrelizumab and alemtuzumab, particularly in modulating immune responses. The findings could significantly influence clinical decisions regarding long-term treatment strategies for MS patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• IRCCS San Raffaele
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Massimo Filippi — IRCCS San Raffaele
• Study coordinator: Angela Genchi
• Email: genchi.angela@hst.it
• Phone: +390226452846

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.