Text Size

Long-Term Safety and Efficacy Study of BIIB017 (ATTAIN)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01332019
First received: March 24, 2011
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this Extension Study is to determine the long-term safety, tolerability, and MS outcomes of BIIB017 in subjects completing Study 105MS301 (ADVANCE).


Condition Intervention Phase
Relapsing Multiple Sclerosis
 Drug: BIIB017
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The incidence of adverse events and lab abnormalities as a measure of the long-term safety and tolerability of BIIB017 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MS outcomes assessed using the annualized relapse rate (ARR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • MRI outcomes assessed using the number and volume of brain lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disability outcomes assessed using the Expanded Disability Status Score (EDSS) and Symbol Digit Modalities Test (SDMT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of Life assessed using the SF-12, EQ-5D, and MSIS-29 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 β-1a
Experimental: 2
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 β-1a

Detailed Description:

This is a global, multicenter, parallel-group, dose-frequency blinded study. This study is an extension of Biogen Idec Study 105MS301 (ADVANCE) and is designed to evaluate the long-term safety and tolerability of BIIB017, and the long-term effect of BIIB017 on MS outcomes. The study will be conducted at approximately 200 sites.

All subjects will receive an SC injection (self administration) of study treatment (either BIIB017 or placebo) every 2 weeks. Subjects will continue to administer BIIB017 at the same dose regimen they were following during their participation in the second treatment year of ADVANCE as follows:

  • Group 1: subjects will receive 125 mcg BIIB017 SC every 2 weeks for 96 weeks
  • Group 2: subjects will receive 125 mcg BIIB017 SC every 4 weeks for 96 weeks

To ensure blinding between dose-frequency groups, each subject will receive one injection of BIIB017 or placebo every 2 weeks. The treatment period is 2 years in duration.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301.

Exclusion Criteria:

  • Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301.
  • Subjects with any clinically significant lab abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major 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: NCT01332019

  Show 158 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01332019     History of Changes
Other Study ID Numbers: 105MS302
Study First Received: March 24, 2011
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Turkey: Ethics Committee
Serbia: Ethics Committee
Ukraine: Ministry of Health
Greece: Ethics Committee
Mexico: Comisión Federal para la Protección contra riesgos sanitarios (COFEPRIS)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Canada: Canadian Institutes of Health Research
Estonia: The State Agency of Medicine
Spain: Comité Ético de Investigación Clínica
Bulgaria: Ministry of Health
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
United Kingdom: Department of Health
New Zealand: Food Safety Authority
Chile: Instituto de Salud Pública (ISP)
India: Central Drugs Standard Control Organization
Belgium: Directorate general for the protection of Public health: Medicines
Romania: Ethics Committee

Keywords provided by Biogen Idec:
Subcutaneous
Extension
Interferon
MS
PEGylated
 Injectable
SC
PEG
Relapsing

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 May 19, 2013