A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)

Merck KGaA, Darmstadt, Germany1 site in 1 country8 target enrollmentFebruary 2015

ConditionsMultiple Sclerosis, Relapsing-remitting

Overview

Phase: N/A
Intervention: Not specified
Conditions: Multiple Sclerosis, Relapsing-remitting
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 8
Locations: 1
Primary Endpoint: Percentage of Relapse-free Subjects
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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™.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Relapse-free Subjects

Time Frame: 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 Outcomes

Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™(Up to 24 months)
Annualized Relapse Rate(Months 12 and 24)