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This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.
The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsing Multiple Sclerosis Cohort | Patients with relapsing forms of multiple sclerosis who had newly initiated anti-CD20 treatment after March 2017. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values | Low immunoglobulin values were defined as greater than or equal to 1 immunoglobulin G (IgG) lab value of less than 500 milligrams per deciliter (mg/dL) or greater than or equal to 1 immunoglobulin M (IgM) lab value of less than 25 mg/dL. | Up to 5 years |
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Inclusion criteria:
Exclusion criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab |
| Up to 5 years |
| Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab | Risk factors included: age and disease duration. | Up to 5 years |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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