No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
7,466 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults diagnosed with multiple sclerosis who are considering treatment with Kesimpta or Ocrevus. Participants will be monitored over time to compare the effectiveness of these two medications.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with multiple sclerosis.
I have had no claims for Kesimpta or Ocrevus in the past year.
I have had at least two doctor visits related to my multiple sclerosis.
I have been enrolled in a healthcare plan for at least 12 months before and 6 months after the start date.
I have been taking Kesimpta or Ocrevus for at least 6 months.
You may not be able to join if
I do not meet the inclusion criteria.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 cos…
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.
Trial Locations
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Status
Eligibility Criteria
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 t…
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.
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