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Purpose

This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria: - ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period. - No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim. - ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with MS recorded as the primary diagnosis in the 12 months prior to or on index date. - ≥18 years of age on index date. - Continuous healthcare plan enrollment for ≥12 months prior to index date and ≥6 months after index date. - Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date. Patients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria: - Included in pooled OMB cohort or pooled OCR cohort. - No claims for a disease-modifying therapy (DMT) used for the treatment of MS in the 12-month baseline period.

Exclusion Criteria

• Patients who do not meet the study inclusion criteria. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Treatment-naïve OMB Cohort MS patients initiated on OMB who have not used a DMT for the treatment of MS in the 12-month period prior to index date.
Treatment-naïve OCR Cohort MS patients initiated on OCR who have not used a DMT for the treatment of MS in the 12-month period prior to index date.
Pooled OMB Cohort All patients diagnosed with MS initiated on OMB including treatment-naïve and -experienced patients.
Pooled OCR Cohort All patients diagnosed with MS initiated on OCR including treatment-naïve and -experienced patients.

Recruiting Locations

Novartis
East Hanover, New Jersey 07936

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.