Efficacy and Safety Study of BIIB017 - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. [ Time Frame: 1 year +2 year ] [ Designated as safety issue: No ]

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: PEGylated Interferon beta-1a PEG IFN ß-1a
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: PEGylated Interferon beta-1a PEG IFN ß-1a
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: PEGylated Interferon beta-1a PEG IFN ß-1a

Detailed Description:

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

Criteria

Inclusion Criteria:

Aged 18 to 65 years old, inclusive, at the time of informed consent.
Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4
Must have an EDSS score between 0.0 and 5.0.
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months

Exclusion Criteria:

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906399

Show 160 Study Locations

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

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

Keywords provided by Biogen Idec:

interferon
injectable
MS
SC
PEGylated

relapsing
PEG
multiple sclerosis
subcutaneous

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 09, 2012