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| Name | Class |
|---|---|
| Merck Serono Limited, UK | INDUSTRY |
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The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the United Kingdom (UK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebif cohort | Subject will receive Rebif as the treatment medication as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches. |
| |
| Other DMT cohort | Subjects will receive DMT other than Rebif as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif | Drug | The subjects will receive Rebif as per the current practices or as directed by the physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction | The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts. | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Work Productivity | Work Productivity and Activity Impairment (WPAI) Questionnaire | 96 weeks |
| Health Related Quality of Life | Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Serono Limited, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the | Merck KGaA Communication Center For Locations | United Kingdom |
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| Other: Disease modifying therapies (DMT) | Other | The subjects will receive other DMTs as per the current practices or as directed by the physician. |
|
| 96 weeks |
| Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire | 96 weeks |
| Device satisfaction | Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects. | 96 weeks |
| Evaluation of support services | Patient evaluation of Manufacturer, Homecare and NHS support services | 96 weeks |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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