Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)

Terminated

• Conditions: Multiple Sclerosis, Relapsing-remitting
• Interventions: Device: RebiSmart®2.0; Device: MSdialog™

• Registration Number: NCT02394782
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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™.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2015-11
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsing-remitting Multiple Sclerosis	RebiSmart®2.0	-
Relapsing-remitting Multiple Sclerosis	MSdialog™	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Please contact the Merck KGaA Communication Center; 🇩🇪 Darmstadt, Germany