An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™. (SMART)
|ClinicalTrials.gov Identifier: NCT01108887|
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : September 17, 2013
|Condition or disease|
|Multiple Sclerosis, Relapsing-Remitting|
This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).
- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge
- To assess effectiveness and convenience of treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge.
|Study Type :||Observational|
|Actual Enrollment :||912 participants|
|Official Title:||Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.|
|Study Start Date :||September 2009|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
- Adherence to treatment [ Time Frame: Baseline to 12 months of treatment ]Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.
- Effectiveness and convenience of treatment [ Time Frame: Baseline to 12 months of treatment ]Overall evaluation of RebiSmart use based on Convenience Questionnaire; reasons for missed injections; proportion of subjects who prematurely terminated treatment and reasons why, proportion of subjects remaining disease-free, proportion of subjects relapse free; mean number of relapses
- Safety of treatment [ Time Frame: Baseline to 12 months ]Recording of adverse reactions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108887
|Merck Serono Observational Site|
|Study Director:||Medical Responsible||Merck Serono, a division of Merck KGaA, Darmstadt, Germany|