Clinical trial NCT06897657: A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
Official title: Retrospective, Non-interventional Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Disease modifying therapy
Medication adherence
Ofatumumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, non-interventional cohort study.

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.


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

Primary outcomes:
measure: Medical Possession Ratio (MPR)
timeFrame: Up to 13 months
measure: Number of Patients by MPR Category
timeFrame: Up to 13 months
Secondary outcomes:
measure: Number of Patients by Demographic Category
timeFrame: Baseline
measure: Time From MS Diagnosis to Ofatumumab Initiation
timeFrame: Baseline
measure: Number of Patients by Comorbidity
timeFrame: Baseline
measure: Number of Patients who Received at Least one DMT Prior to Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Number of Prior DMTs Reported
timeFrame: Up to 13 months
measure: Number of Patients by Prior DMT Category
timeFrame: Up to 13 months
measure: Number of Patients by Reason for Switch from Other DMT to Ofatumumab
timeFrame: Up to 13 months
measure: Individual Annualized Relapse Rate (ARR) Before Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Total ARR Before Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Individual ARR After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Total ARR After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Average Expanded Disability Status Scale (EDSS) Score Before Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Average EDSS Score After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Absolute Change in Average EDSS Score
timeFrame: Up to 26 months
measure: Average Number of T1 and T2 Lesions Before Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Average Number of T1 and T2 Lesions After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Individual ARR After Ofatumumab Initiation by MPR Category
timeFrame: Up to 13 months
measure: Total ARR After Ofatumumab Initiation by MPR Category
timeFrame: Up to 13 months
measure: Average EDSS Score Before Ofatumumab Initiation by MPR Category
timeFrame: Up to 13 months
measure: Average EDSS Score After Ofatumumab Initiation by MPR Category
timeFrame: Up to 13 months
measure: Absolute Change in Average EDSS Score by MPR Category
timeFrame: Up to 26 months
measure: Number of Patients per MPR Category by Type of KC PSP Services Received
timeFrame: Up to 13 months
measure: Number of Medical Visits After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Annualized Medical Visit Rate After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Number of MS-related Medical Visits After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Annualized MS-related Medical Visit Rate After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Number of Patients With Medically Reported Adherence (MRA) After Ofatumumab Initiation
timeFrame: Up to 13 months
measure: Number of Patients by Reason for Discontinuation of Ofatumumab
timeFrame: Up to 13 months
measure: Number of Patients who Switched From Ofatumumab to an Alternative DMT
timeFrame: Up to 13 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: