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

April 22, 2016 updated by: Merck KGaA, Darmstadt, Germany

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)

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 Overview

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Darmstadt, Germany
        • Please contact the Merck KGaA Communication Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participating sites will identify and recruit eligible subjects using appropriate recruitment strategies in accordance with any local approvals/regulations for observational studies e.g. via clinics, referrals, advertisements, patient databases etc.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Relapsing-remitting Multiple Sclerosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate
Time Frame: 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.
Months 12 and 24
Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™
Time Frame: 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).
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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