Clinical trial NCT06760624: Effectiveness of Ofatumumab in Real-world Practice
Official title: Effectiveness of Ofatumumab in Real-world Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 779
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, noninterventional cohort study.

Brief summary: This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration \[FDA\] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy \[DMT\]), discontinuation of enrollment, or end of study period on 31 December 2023.


Eligibility criteria: Inclusion criteria:

1. Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
2. One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
3. One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision \[ICD-10\] code G35.xx) any time before the index date and up to 6 months after the index date.
4. Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
5. Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.

Exclusion criteria:

None.

Primary outcomes:
measure: Annualized Relapse Rate (ARR) in the Pre-Index Period
timeFrame: 12 months
measure: ARR in the Post-index Period
timeFrame: An average of approximately 16 months
measure: Incidence Rate Ratio
timeFrame: An average of approximately 16 months
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Mean Deyo-Charlson Comorbidity Index
timeFrame: Baseline
measure: Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders
timeFrame: Baseline
measure: Number of Patients Categorized by Top Five Selected Comorbidities
timeFrame: Baseline
measure: Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions
timeFrame: Baseline
measure: Number of Patients Categorized by MS Disability Level
timeFrame: Baseline
measure: Number of Patients Categorized by DMT Used in the Pre-index Period
timeFrame: Baseline
measure: Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)
timeFrame: 12 months
measure: Pre-index HCRU: Number of Days of MS-related Hospitalization PPY
timeFrame: 12 months
measure: Pre-index HCRU: Number of MS-related Healthcare Visits PPY
timeFrame: 12 months
measure: Post-index HCRU: Number of MS-related Hospitalizations PPY
timeFrame: An average of approximately 16 months
measure: Post-index HCRU: Number of Days of MS-related Hospitalization PPY
timeFrame: An average of approximately 16 months
measure: Post-index HCRU: Number of MS-related Healthcare Visits PPY
timeFrame: An average of approximately 16 months
measure: Incidence Rate Ratio of MS-related Hospitalizations
timeFrame: An average of approximately 16 months
measure: Incidence Rate Ratio of Days of MS-related Hospitalizations
timeFrame: An average of approximately 16 months
measure: Incidence Rate Ratio of MS-related Emergency Department Visits
timeFrame: An average of approximately 16 months
measure: Incidence Rate Ratio of MS-related Outpatient Visits
timeFrame: An average of approximately 16 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: