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

RECRUITINGSponsored by IRCCS San Raffaele
Actively Recruiting
SponsorIRCCS San Raffaele
Started2022-09-02
Est. completion2027-09-02
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06267781

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions1

Multiple Sclerosis

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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