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The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a | Drug | Interferon beta-1a will not be provided as a part of this study. Participants will receive Interferon beta-1a as prescribed by their treating physician prior to enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months | Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in EQ-5D VAS at 6, 18 and 24 months | Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status. | Baseline and Months 6, 18 and 24 |
| Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) who meet the criteria for prescription of Interferon Beta-1a IM at up to 20 Belgian institutions may participate into this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bonheiden | Antwerp | 2820 | Belgium | ||
| Research Site |
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The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The scores are generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. |
| Baseline and Months 6, 12, 18 and 24 |
| Change from Baseline in EQ-5D Summary Score | The EQ-5D is a self-administered questionnaire consisting of 5 questions pertaining to specific health states (i.e., mobility, self-care, pain/discomfort, usual activities and anxiety/depression), with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 is derived from these five dimensions where a score of 1 indicates the best health state. | Baseline and Months 6, 12, 18 and 24 |
| Convenience | Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks. | Baseline and Months 6, 12, 18 and 24 |
| Correlation between VAS and MSIS29 | The correlation between the EQ-5D visual analog scale and Multiple Sclerosis Impact Scale 29 scores will be assessed using the Spearman correlation coefficient. | Baseline and Months 6, 12, 18 and 24 |
| Correlation between VAS and Convenience questionnaire | The correlation between the EQ-5D visual analog scale and convenience questionnaire results will be assessed using the Spearman correlation coefficient. | Baseline and Months 6, 12, 18 and 24 |
| Middelheim |
| Antwerp |
| 2020 |
| Belgium |
| Research Site | Ottignies | Brabant Wallon | 1340 | Belgium |
| Research Site | Woluwe | Brussels Capital | 1200 | Belgium |
| Research Site | Aalst | East Flanders | 9300 | Belgium |
| Research Site | Saint Niklaas | East Flanders | 9100 | Belgium |
| Research Site | Tielt | East Flanders | 8700 | Belgium |
| Research Site | Baudour | Hainaut | 7331 | Belgium |
| Research Site | Charleroi | Hainaut | 6000 | Belgium |
| Research Site | Charleroi | Hainaut | 6042 | Belgium |
| Research Site | La Louvière | Hainaut | 7100 | Belgium |
| Research Site | Tournai | Hainaut | 7500 | Belgium |
| Research Site | Hasselt | Limburg | 3500 | Belgium |
| Research Site | Liège | Liège | 4000 | Belgium |
| Research Site | Verviers | Liège | 4800 | Belgium |
| Research Site | Libramont | Luxembourg | 6800 | Belgium |
| Research Site | Sijsele | West Flanders | 8340 | Belgium |
| 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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