NCT07566988

Brief Summary

The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,604

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisAnti-CD20 monoclonal antibodyOfatumumabOcrelizumabReal-world evidenceComparative effectivenessAnnualized relapse rateHealthcare resource utilization

Outcome Measures

Primary Outcomes (1)

  • Annualized Relapse Rate (ARR) in Treatment-Naïve Patients

    ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.

    Up to approximately 3 years and 11 months

Secondary Outcomes (4)

  • ARR in All Patients

    Up to approximately 3 years and 11 months

  • Healthcare Visits PPY

    Up to approximately 3 years and 11 months

  • Inpatient Days PPY

    Up to approximately 3 years and 11 months

  • Difference in Healthcare Costs in OMB Versus OCR

    Up to approximately 3 years and 11 months

Study Arms (4)

Pooled OMB Cohort

Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020.

Pooled OCR Cohort

Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020.

Treatment-naïve OMB Cohort

Adult MS patients who initiated OMB treatment and who did not use a DMT for MS treatment in the 12-month period before starting OMB.

Treatment-naïve OCR Cohort

Adult MS patients who initiated OCR treatment and who did not use a DMT for MS treatment in the 12-month period before starting OCR.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who had a first claim for either ofatumumab or ocrelizumab from August 20, 2020, with no claim for either drug during the preceding 12 months.

You may qualify if:

  • Pooled OMB and OCR Cohorts:
  • ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
  • No claims for OMB or OCR within the 12 months prior to the index date.
  • ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th 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 a diagnosis of MS in the first position 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 (baseline period) and ≥6 months after index date (follow-up period).
  • Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date.
  • Treatment-naïve OMB and OCR Cohorts:
  • Included in Pooled OMB Cohort or Pooled OCR Cohort.
  • No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

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

April 28, 2026

First Posted

May 5, 2026

Study Start

October 25, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)