Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis (ADVANCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00906399
First received: May 20, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The primary objective of this study is to determine the efficacy of BIIB017 (PEGylated Interferon Beta-1a) in reducing the Annualized Relapse Rate (ARR) in participants with RMS at 1 year. The secondary objectives of this study are to determine, whether efficacy PEGylated Interferon Beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans, reducing the proportion of participants who relapsed and slowing the progression of disability.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Drug: Placebo
Phase 3

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:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Annualized Relapse Rate (ARR). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    A relapse is defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings. The relapse rate for each treatment group will be calculated as the total number of relapses experienced in the group divided by the total number of days in the study for the group, and the ratio multiplied by 365.


Secondary Outcome Measures:
  • The number of new or newly enlarging T2 hyperintense lesions on brain MRI scans [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number of participants with relapses [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Time to sustained progression of disability [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Sustained disability progression is defined as: at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS


Enrollment: 1516
Study Start Date: June 2009
Study Completion Date: October 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo every 2 weeks for 48 weeks followed by 125 µg PEGylated Interferon Beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
  • PEG IFN ß-1a
  • PEGylated Interferon beta-1a
  • BIIB017
Drug: Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Experimental: BIIB017 Q2W
125 µg PEGylated Interferon Beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
  • PEG IFN ß-1a
  • PEGylated Interferon beta-1a
  • BIIB017
Experimental: BIIB017 Q4W
125 µg PEGylated Interferon Beta-1a subcutaneously every 4 weeks (Q4W) and placebo every other 4 weeks for 96 weeks.
Drug: BIIB017 (PEGylated Interferon Beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Other Names:
  • PEG IFN ß-1a
  • PEGylated Interferon beta-1a
  • BIIB017
Drug: Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), as defined by McDonald criteria #1-4
  • Must have an Expanded Disability Status Scale (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

Key Exclusion Criteria:

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00906399     History of Changes
Other Study ID Numbers: 105MS301, 2008-006333-27
Study First Received: May 20, 2009
Last Updated: June 17, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: Ministry of Public Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Serbia: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Ukraine: State Expert Centre of the Ministry of Health of Ukraine
Greece: Ministry of Health and Welfare
Greece: Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Estonia: The State Agency of Medicine
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Peru: Instituto Nacional de Salud
Poland: Ministry of Health
Russia: Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Peru: Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Croatia: Ministry of Health and Social Care
Georgia: Ministry of Health
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Latvia: State Agency of Medicines
United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
India: Central Drugs Standard Control Organization
Romania: Ethics Committee
Russia: Ministry of Health of the Russian Federation

Keywords provided by Biogen Idec:
interferon
injectable
MS
SC
PEGylated
Interferon beta-1a
relapsing
PEG
multiple sclerosis
subcutaneous

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 July 22, 2014