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:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT05423769
Eligibility Criteria:
Inclusion Criteria:
1. Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
2. Males and females who are ≥ 18 years old.
3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
1. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
2. Switched patients from Gilenya®, Novartis, or
3. Switched patients from interferon beta (IFNβ).
4. Patients who agree to participate in the study and provide a written informed consent.
Exclusion Criteria:
1. Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
2. Patients lacking immunity against varicella zoster virus (VZV).
3. Patients participating in other clinical studies.
4. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05423769
Study Brief:
Protocol Section:
NCT05423769