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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT03101735
Eligibility Criteria:
Inclusion Criteria:
* Persons aged 18-65 years.
* Patients with a confirmed diagnosis of RRMS.
* Patients for whom the decision to prescribe therapy with Tecfidera®, according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study. The assignment of a patient to this therapeutic strategy is not decided in advance, but falls within current practice, while the prescription of Tecfidera® is clearly separated from the physician's decision to include the patient in the current study.
* Patients must have signed an informed consent document.
* Patients must be able to read, understand and complete the study specific questionnaire.
Exclusion Criteria:
* Patients having other forms of MS, like Clinically Isolated Syndrome (CIS) or progressive forms.
* Patients who have initiated treatment with Tecfidera® more than 7 days before study enrolment or have received DMF at any different time prior to this period.
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
* Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with Tecfidera®.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03101735
Study Brief:
Protocol Section:
NCT03101735