Clinical trial NCT02394782: Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: Multiple sclerosis, relapsing-remitting
Rebif
Interferon beta-1a
RebiSmart®2.0
MSdialog™
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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™.


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

Primary outcomes:
measure: Percentage of Relapse-free Subjects
timeFrame: Up to 24 months
Secondary outcomes:
measure: Annualized Relapse Rate
timeFrame: Months 12 and 24
measure: Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: