Recruiting

Ofatumumab vs. Ocrelizumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07779460

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07779460

Start date

Apr 8, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

7466 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients [ Time Frame: Up to approximately 5 years, 4 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-21.