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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT06345157
Eligibility Criteria:
Inclusion Criteria:
1. Male or female outpatients ≥18 years old.
2. Patients diagnosed with RRMS (McDonald criteria 2017).
3. Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
4. Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.
Exclusion Criteria:
1. Patients outside the approved label of ofatumumab.
2. Pregnant and lactating women.
3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
4. Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06345157
Study Brief:
Protocol Section:
NCT06345157