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

NCT06897657 | Completed

• 1 other identifier: COMB157GGB01
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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

Keywords

Disease modifying therapy; Medication adherence; Ofatumumab

Outcome Measures

Primary Outcomes (2)

• Medical Possession Ratio (MPR)

  MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period.

  Up to 13 months

• Number of Patients by MPR Category

  MPR was reported as the number of days covered by ofatumumab injections in a given time period, divided by the number of days in the time period. MPR categories: * High MPR: MPR = 1.0 * Intermediate MPR: 0.8 ≤ MPR \<1.0 * Low MPR: MPR \<0.8.

  Up to 13 months

Secondary Outcomes (29)

• Number of Patients by Demographic Category

  Baseline

• Time From MS Diagnosis to Ofatumumab Initiation

  Baseline

• Number of Patients by Comorbidity

  Baseline

• Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation

  Up to 13 months

• Number of Prior DMTs Reported

  Up to 13 months

Study Arms (3)

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.

KC PSP User Cohort

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

Non-KC PSP User Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

You may qualify if:

• 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:
• Patient was alive at start of data collection and patient consented prior to start of their data collection or,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Medication Adherence

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: November 6, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)