This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
Study Type
OBSERVATIONAL
Enrollment
8
Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
Please contact the Merck KGaA Communication Center
Darmstadt, Germany
Percentage of Relapse-free Subjects
Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement.
Time frame: Up to 24 months
Annualized Relapse Rate
Annualized relapse rate is calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Time frame: Months 12 and 24
Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™
Normalized scores are calculated in the range of 0 - 100; where 0 = the worst QoL status and 100 = the best QoL status (as self-assessed by the subject).
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.