Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT05777902
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05777902
Study Brief:
Protocol Section:
NCT05777902