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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00906399 |
Purpose
To determine if treatment with BIIB017 can decrease the number of MS relapses during a certain time period for patients with RMS. Other goals of the study are to determine if, over time, BIIB017 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Multiple Sclerosis |
Drug: BIIB017 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis |
| Enrollment: | 1500 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.
|
Drug: BIIB017
BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
Other Names:
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Experimental: 2
125 mcg BIIB017 SC every 2 weeks for 96 weeks.
|
Drug: BIIB017
BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
Other Names:
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Experimental: 3
125 mcg BIIB017 SC every 4 weeks for 96 weeks.
|
Drug: BIIB017
BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
Other Names:
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BIIB017, a PEGylated form of interferon beta-1a (IFN β-1a), is being developed as a novel therapeutic agent for the treatment of multiple sclerosis (MS). Despite recent approval of new therapeutic agents for MS, there continues to be a high unmet medical need in this patient population.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Show 160 Study Locations
More Information
| Responsible Party: | Study Director: Biogen Idec Inc., MD Biogen Idec, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00906399 History of Changes |
| Other Study ID Numbers: | 105MS301 |
| Study First Received: | May 20, 2009 |
| Last Updated: | January 12, 2012 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Turkey: Ethics Committee; Serbia: Ethics Committee; Ukraine: Ministry of Health; Greece: Ethics Committee; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Canada: Canadian Institutes of Health Research; Bulgaria: Ministry of Health; Estonia: The State Agency of Medicine; Spain: Comité Ético de Investigación Clínica; Poland: Ministry of Health; Russia: Ethics Committee; Netherlands: Independent Ethics Committee; Czech Republic: Ethics Committee; Peru: Ethics Committee; Germany: Ethics Commission; Croatia: Agency for Medicinal Product and Medical Devices; Latvia: State Agency of Medicines; Israel: Ethics Commission; United States: Food and Drug Administration; United Kingdom: Department of Health; New Zealand: Food Safety Authority; India: Central Drugs Standard Control Organization; Belgium: Directorate general for the protection of Public health: Medicines; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Romania: Ethics Committee; Brazil: Ethics Committee |
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interferon injectable MS SC PEGylated |
relapsing PEG multiple sclerosis subcutaneous |
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Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta 1a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |