Tracking Information
Start Date ICMJE | January 2009 |
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Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 22, 2008) | Time to conversion to CDMS defined by either a second attack or a sustained increase (greater than or equal to 1.5 points) in the EDSS score (as defined in study 27025 (REFLEX)), from randomization in study 27025 (REFLEX) up to Month 36. [ Time Frame: 36 Months from randomization in study 27025 (REFLEX) ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00813709 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 5, 2009) | Time to conversion to CDMS (only at M36); Time to confirmed EDSS progression (≥1.0 point, confirmed during a visit performed 6 months later); MRI endpoints; Other secondary endpoints (PASAT, relapse-free subjects...); Safety endpoints (SAEs,BAbs&Nabs.) [ Time Frame: 60 months from randomisation in study 27025 (REFLEX) ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: December 22, 2008) | Time to conversion to CDMS (only at M36); Time to confirmed EDSS progression (≥1.0 point, confirmed during a visit performed 6 months later); MRI endpoints; Other secondary endpoints (PASAT, relapse-free subjects...); Safety endpoints (SAEs,BAbs&Nabs.) [ Time Frame: 36 and 60 months from randomisation in study 27025 (REFLEX) ] [ Designated as safety issue: No ] |
Descriptive Information
Brief Title ICMJE | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) |
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Official Title ICMJE | Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION) |
Brief Summary | REFLEXION is a double-blind (blinding of both investigator and patient) extension of the study 27025 (REFLEX). The purpose of the study is to obtain long-term follow-up data in patients with clinically definite Multiple Scleroris (MS) and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (RNF). |
Detailed Description | The objective of the study is to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to CDMS conversion up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX). Furthermore, the study is intended to explore whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability (including development of secondary progressive MS) and reduces disease activity (including the annual relapse rate) in the long term (up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX)). The study will also assess the long-term safety profile of RNF (up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX)). |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 430 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Argentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Israel, Italy, Latvia, Lebanon, Morocco, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Turkey |
Administrative Information
NCT ID ICMJE | NCT00813709 | ||||
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Responsible Party | Bettina Stubinski, MD, Merck Serono S.A. - Geneva | ||||
Study ID Numbers ICMJE | 28981 | ||||
Study Sponsor ICMJE | EMD Serono | ||||
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Information Provided By | EMD Serono |