A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice

NCT07779460 | Recruiting

• 1 other identifier: COMB157GUS43
• Study Type: observational
• Target: 7,466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Ofatumumab; Ocrelizumab; Anti-CD20 therapy; Comparative effectiveness; Real-world evidence

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients

  ARR is defined as the number of relapse episodes per patient-year (PPY).

  Up to approximately 5 years, 4 months

Secondary Outcomes (4)

• ARR in All MS Patients

  Up to approximately 5 years, 4 months

• Number of All-cause and MS-related Healthcare Visits PPY

  Up to approximately 5 years, 4 months

• Total All-cause and MS-related Healthcare Costs (HCC) PPY

  Up to approximately 5 years, 4 months

• Time From Treatment Initiation to First Relapse

  Up to approximately 5 years, 4 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS newly initiated on OMB or OCR in real-world practice.

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)