University of British Columbia
Vancouver, Canada
NCT Number: NCT01128075
This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
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Notify Me18 year–65 year
All sexes
Observational
Vancouver, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electronic self-injection device (RebiSmart™) to inject Rebif®
Other names: Rebif
Time frame: 24 weeks
Time frame: 96 weeks
Time frame: 96 weeks
Time frame: 96 weeks
Measuring the number of injections received relative to the time on study
Time frame: 96 weeks
Measured by the short version of Rao's Brief Repeatable Battery (BRB)
Time frame: 96 weeks
Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)
Time frame: 96 weeks
A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.
Merck KGaA, Darmstadt, Germany
Industry
Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)
Acronym: MEASURE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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