NCT06897657

A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients

Retrospective, Non-interventional Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with National Health Service (NHS) databases and/or homecare and pharmacy services prescribing ofatumumab were identified and recruited for study participation using a feasibility assessment exercise. The study index identification window spanned from 26 March 2021 to 30 June 2023 (or latest data available prior to start of study data extraction). The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window. From index date, patients were followed up until death, up to 13 months after index date, loss to follow-up, or end of study index identification window (whichever came first). For patients who consented to the use of their data, participating sites transcribed protocol required patient data from existing individual patient medical records into an electronic case report form (eCRF). The end of study was defined as the date of last data query resolution (i.e., all data had been recorded in the eCRF and all data queries resolved to allow database lock to occur). This ensured that all data was available to answer the research questions in the study.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2025-03-27
• Last updated: 2025-03-27

Locations

1 site across 1 country: United States