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

NCT ID: NCT06897657

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-07-25

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Overall MS Cohort

Adult patients with relapsing-remitting multiple sclerosis (RMS) who were prescribed ofatumumab from either an MS clinic participating in the Kesimpta Connect (KC) patient support program (PSP) or an MS clinic not participating in the KC PSP.

No interventions assigned to this group

KC PSP User Cohort

Adult patients with RMS who were prescribed ofatumumab from an MS clinic participating in the KC PSP.

No interventions assigned to this group

Non-KC PSP User Cohort

Adult patients with RMS who were prescribed ofatumumab from an MS clinic not participating in the KC PSP.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

COMB157GGB01

Identifier Type: -

Identifier Source: org_study_id