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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT06897657
Eligibility Criteria:
Inclusion criteria:
Patients were included in the study if they met all of the following criteria:
* Patient was prescribed ofatumumab within the UK approved marketing authorization
* Patient initiated ofatumumab via participating MS clinic with or without KC PSP
* Patients initiated ofatumumab during the index identification window
* Authorized to collect study data:
1. Patient was alive at start of data collection and patient consented prior to start of their data collection or,
2. Patient was deceased at start of data collection and a member of the patient's direct care team had a pre-existing right to access patient medical record
* Specifically for adherence analyses: Patients were required to have a minimum of 6 months of follow-up post index date available to make this assessment
* Specifically for clinical effectiveness analyses: Patients were required to have a minimum of 6 months look-back pre-index date and minimum 6 months follow-up post index date available to make this assessment.
Exclusion criteria:
Patients were excluded from the study if they met the following criteria:
• Patient prescribed ofatumumab outside the approved marketing authorization (i.e., under off-label prescribing) at any point within the patients record
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06897657
Study Brief:
Protocol Section:
NCT06897657