Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGInterferon beta-1a
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.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization * Study enrollment must occur prior to 4th weekly administration of IFN beta-1a * Able to understand and complete a self-administered questionnaire * No contra-indications for IFN beta-1a Key
Exclusion criteria
* Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component * Subjects with primary or secondary progressive MS * Subjects with current severe depression and/or suicidal ideation * Pregnant women * Subjects participating in another clinical trial * Subjects who do not want to participate in the study NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months | Baseline and Month 12 | Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score | Baseline and Months 6, 12, 18 and 24 | 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. |
| Change from Baseline in EQ-5D Summary Score | Baseline and Months 6, 12, 18 and 24 | 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. |
| Change from Baseline in EQ-5D VAS at 6, 18 and 24 months | Baseline and Months 6, 18 and 24 | Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status. |
| Correlation between VAS and MSIS29 | Baseline and Months 6, 12, 18 and 24 | The correlation between the EQ-5D visual analog scale and Multiple Sclerosis Impact Scale 29 scores will be assessed using the Spearman correlation coefficient. |
| Correlation between VAS and Convenience questionnaire | Baseline and Months 6, 12, 18 and 24 | The correlation between the EQ-5D visual analog scale and convenience questionnaire results will be assessed using the Spearman correlation coefficient. |
| Convenience | Baseline and Months 6, 12, 18 and 24 | Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks. |
Countries
Belgium
Outcome results
None listed