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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00813709 |
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).
Condition | Intervention | Phase |
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Multiple Sclerosis Clinically Isolated Syndrome |
Drug: RNF Drug: Rebif® New Formulation (RNF) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 430 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: RNF
Drug RNF 44 mcg tiw sc
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2: Experimental |
Drug: RNF
Drug RNF 44 mcg ow sc
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3: Experimental |
Drug: RNF
Drug RNF 44 mcg tiw sc (having originally been randomised to placebo in previous study 27025)
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4 |
Drug: Rebif® New Formulation (RNF)
Drug RNF 44 mcg tiw sc for all patients when they reach CDMS
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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)).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bettina Stubinski, MD | Merck Serono S.A. - Geneva |
Responsible Party: | Merck Serono S.A. - Geneva ( Bettina Stubinski, MD ) |
Study ID Numbers: | 28981 |
Study First Received: | December 22, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00813709 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Agency for Health and Food Safety; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Bulgaria: Bulgarian Drug Agency; Canada: Canadian Institutes of Health Research; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ministry of Health and Welfare; Israel: Ministry of Health; Italy: Ethics Committee; Latvia: State Agency of Medicines; Morocco: Ministry of Public Health; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Saudi Arabia: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Turkey: Ministry of Health |
Interferon 1-beta Clinical Definite Multiple Sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta 1a |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Disease Pathologic Processes Immune System Diseases Syndrome Nervous System Diseases |