Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration.

Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Treatments: Ozanimod

Criteria

Inclusion Criteria:

• 1) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering the study;

Exclusion Criteria:

• The presence of any of the following will exclude a patient from study enrolment:

1. Ongoing immunomodulatory or immunosuppressive treatment;

2. Other autoimmune comorbidities (i.e. antiphospolipid syndrome);

3. Treatment with steroids in the last 30 days before enrollment;

4. Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days;

5. Patients unable to read and understand the documents of the study.

6. Participation in any interventional clinical trials or compassionate use programs

7. Contraindications and "not-recommendations" reported in SmP