NCT06267781Recruiting
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.
Source: ClinicalTrials.gov · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jan 2024
- Start date
- 2 Sept 2022
- Primary completion date
- 2 Sept 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Multiple sclerosis
- NCT number
- NCT06267781
What you commit to
- Study type: Observational
- Planned participants: 30
- From 2 Sept 2022 to the primary completion date, 2 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known intolerances/allergies to the active substance or the excipients contained in the DMT and/or contraindications according to product information
Other
- Diagnosis of PPMS or SPMS according to the 2017 McDonald criteria
Who the study is looking for
- 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);
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.