Multiple Sclerosis, Relapsing-remitting
Conditions
Keywords
Multiple sclerosis, relapsing-remitting, Rebif, Interferon beta-1a, RebiSmart®2.0, MSdialog™
Brief summary
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™.
Interventions
DEVICERebiSmart®2.0
Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
DEVICEMSdialog™
Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with RRMS according to McDonald criteria 2010 * Relapse free within 30 days before Baseline data collection * Treatment with Rebif for 6 months or more prior to informed consent * Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent) * Females of childbearing potential must be willing to use appropriate contraception for the duration of the study * EDSS score less than (\<) 6 * Written informed consent obtained prior to any protocol-required data collection
Exclusion criteria
* Participation in other studies within 30 days before Baseline * Female who is pregnant or breast feeding * Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice) * Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC) * Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Relapse-free Subjects | Up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate | Months 12 and 24 | 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. |
| Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™ | Up to 24 months | 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). |
Countries
Germany
Outcome results
None listed