A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)
Overview
- Phase
- Not Applicable
- Intervention
- Rebif (Interferon beta-1a)
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 594
- Locations
- 4
- Primary Endpoint
- Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects aged more than or equal to (\>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction
- •Subjects diagnosed with RMS according to the revised McDonald criteria (2010)
- •Treatment naïve or subjects on other DMDs who will switch to Rebif.
- •Subjects will receive 1st Rebif 44 mcg dose after signing informed consent
- •Subjects willing and able to provide signed informed consent.
Exclusion Criteria
- •Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information
- •Subjects participating in other clinical studies/trials
- •Any female subject of childbearing potential who is not on contraceptives
- •Subjects refusal to participate in the study.
Arms & Interventions
Relapsing Multiple Sclerosis (RMS) group
Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)
Intervention: Rebif (Interferon beta-1a)
Outcomes
Primary Outcomes
Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
Time Frame: Month 24
MGLS is a four item self-reported questionnaire to assess medication adherence. It consists of four questions/items evaluating drug intake habits in subjects on chronic therapies with a scoring scheme of "Yes" = 1 (no adherence) and "No" = 0 (adherence). The items are summed to give an overall score, which ranges from 0 to 4 where high adherence=0, medium adherence=1-2 or low adherence=3-4.
Secondary Outcomes
- Percentage of relapse-free subjects(Month 24)
- Percentage of relapse-free subjects based on MGLS Score(Up to 24 month)
- Percentage of subjects on Rebif who discontinued the treatment(up to 24 months)
- Time to treatment discontinuation(up to 24 months)
- Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study(Up to 24 months)
- Reason for treatment discontinuation(up to 24 months)
- Percentage of subjects with expanded disability status scale (EDSS) progression(Month 24)