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This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocrelizumab | patients prescribed with ocrelizumab |
| |
| natalizumab | Patients prescribed with natalizumab |
| |
| ofatumumab | Patients prescribed with ofatumumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocrelizumab | Other | Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with key symptoms associated with the wearing off effect | Number of participants with the following recurring symptoms will be collected:
| Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of wearing off effect symptoms | Based on qualitative score rating | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| Detailed language used to describe the experience of wearing off effect |
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Inclusion Criteria:
Patients who attend the following criteria will be included:
Clinicians who attend the following criteria will be included:
Exclusion Criteria:
Patients will be excluded from the enrollment if:
Clinicians will be excluded from the enrollment if are currently involved as a key opinion leader or receives funding from one of the drug manufacturers
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Adult patients diagnosed with MS and clinicians with experience treating MS from Germany, UK, and US
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Basel | Switzerland |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
| D000069442 | Natalizumab |
| C527517 | ofatumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| natalizumab | Other | Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. |
|
|
| ofatumumab | Other | Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. |
|
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Terms used to describe times when patients MS "gets better" and when it "gets worse" will be collected. |
| Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| Number of participants switching from one therapy to another due to wearing off effect | Number of participants switching from one therapy to another due to wearing off effect will be collected | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| Number of participants who changed the dosing/infusion schedules due to wearing off effect | Number of participants who changed the dosing/infusion schedules due to wearing off effect will be collected | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| Dissimilarities of clinician' and patients' views of wearing off effect | Assessed qualitatively via concept coding techniques | Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |