Comparing Ofatumumab vs Ocrelizumab in Real-World MS Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses US claims data to compare the real-world clinical effectiveness and economic burden of two anti-CD20 therapies, ofatumumab and ocrelizumab, in people with MS. The primary effectiveness measure is annualized relapse rate, while economic impact is assessed through healthcare utilization and costs. Inclusion requires adults with MS who begin either therapy and have continuous coverage in the prior year, with specific MS diagnosis criteria and persistence on the study drug. The analysis will contrast relapse outcomes and healthcare costs between the two cohorts over a defined follow-up period. Lead sponsor is Novartis, with data sources comprising de-identified longitudinal claims data from participating healthcare plans.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.