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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00441103 |
Objectives:
Primary: To evaluate the efficacy of Rebif® New Formulation (RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.
Primary Endpoints: The primary endpoint is the difference between the number of combined unique (CU) active MRI lesions at Week 16 in the RNF group (Group 1) vs. the placebo group (Group 2).
Secondary Endpoints: The secondary endpoint is the difference in the mean number of combined unique (CU) active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 vs. Weeks 17 - 40 for the subjects randomized to Group 2.
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Rebif® New Formulation (IFN-beta-1a) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Two-Arm, Randomized, Double-Blind, Control Group-Compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN-Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis |
Estimated Enrollment: | 150 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
RNF 44 mcg s.c. tiw for 40 weeks
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Drug: Rebif® New Formulation (IFN-beta-1a)
Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.
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2: Placebo Comparator
Matching placebo for 16 weeks, then RNF 44 mcg s.c. tiw for remaining 24 weeks
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Drug: Rebif® New Formulation (IFN-beta-1a)
Rebif® New Formulation (RNF) 44 mcg s.c. tiw for up to 40 weeks. The dose of study medication will be titrated during the initial four-weeks of treatment. Subjects in Group 2 will be switched to RNF 44 mcg s.c. tiw at the end of the initial 16 weeks of treatment, starting a second titration with the same titration schedule as the initial one, while subjects initially assigned to RNF will after Week 16 continue to receive active treatment at the same dose throughout the whole study period, without any re-titration.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
Exclusion Criteria:
Canada | |
Local Medical Information Office | |
Ontario, Canada | |
Germany | |
Local Medical Information Office | |
Munich, Germany | |
Italy | |
Local Medical Information Office | |
Roma, Italy | |
Spain | |
Local Medical Information Office | |
Madrid, Spain | |
Switzerland | |
Local Medical Information Office | |
Zug, Switzerland |
Study Director: | Bettina Stubinski,, MD | Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany |
Responsible Party: | Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany ( Bettina Stubinski, Senior, Medical Director ) |
Study ID Numbers: | 27178, 2006-003037-32 |
Study First Received: | February 26, 2007 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00441103 |
Health Authority: | Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Estonia: The State Agency of Medicine; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ethics Committee; Lithuania: State Medicine Control Agency - Ministry of Health; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Spain: Ministry of Health and Consumption; Switzerland: Swissmedic |
Subjects with relapsing remitting multiple sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta 1a Interferon-beta |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |