Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)
NCT ID: NCT02394782
Last Updated: 2016-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
8 participants
OBSERVATIONAL
2015-02-28
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Relapsing-remitting Multiple Sclerosis
RebiSmart®2.0
Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
MSdialog™
Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
Interventions
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RebiSmart®2.0
Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
MSdialog™
Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Please contact the Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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Other Identifiers
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EMR200136-591
Identifier Type: -
Identifier Source: org_study_id
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