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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT03981003
Eligibility Criteria:
Inclusion Criteria:
* The patient has been correctly informed.
* The patient must have given their informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥)15 years old.
* The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:
* Participates to the OFSEP-HD cohort (ancillary study);
* Has a Expanded Disability Status Scale score comprised between 0 - 7.0;
* With or without Disease Modifying Drug;
* For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
* For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.
Exclusion Criteria:
* Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.
* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient (inability to understand the study, language problem).
* The patient is pregnant or breast-feeding.
* The patient is under 15 years old.
* Inability to answer questionnaires.
* Clinically isolated syndrome (CIS) that does not meet the criteria of MS.
* Radiologically isolated syndrome (RIS).
* Patient with Neuromyelitis optica spectrum disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT03981003
Study Brief:
Protocol Section:
NCT03981003