Relapsing Multiple Sclerosis (RMS)
Conditions
Keywords
Relapsing Multiple Sclerosis, Interferon beta-1a, Rebif®, Morisky Green Levine Medication Adherence Scale
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.
Interventions
Rebif will be administered at a dose of 44 mcg, sc, tiw.
Sponsors
Merck Serono Middle East FZ LLC
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment discontinuation | up to 24 months | — |
| Reason for treatment discontinuation | up to 24 months | The reason for treatment discontinuation will includes: adverse event, lost to follow-up, lack of efficacy, protocol noncompliance, progressive disease, withdrew consent, death, frequency, unrealistic expectations, other |
| Percentage of relapse-free subjects | Month 24 | — |
| Percentage of subjects on Rebif who discontinued the treatment | 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 | — |
| Percentage of relapse-free subjects based on MGLS Score | Up to 24 month | — |
| Percentage of subjects with expanded disability status scale (EDSS) progression | Month 24 | EDSS is used for multiple sclerosis disability assessment. It is a 10 point scale, where 0 indicates normal motor skills, and 10 indicates patient's death. EDSS progression is defined as one point increase sustained for at least three months. |
Countries
Algeria, Argentina, Bahrain, Bulgaria, Egypt, Hungary, Iran, Kuwait, Lebanon, Morocco, Poland, Saudi Arabia, South Korea
Outcome results
None listed