Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01332019
First received: March 24, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The primary objective of this study is to evaluate the long-term safety and tolerability of pegylated interferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue BIIB017 treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue BIIB017 treatment.


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: 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:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of participants with adverse events and laboratory abnormalities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annualized relapse rate (ARR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. 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.

  • Percentage of participants who relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse are considered part of the same relapse.

  • The total number of new or newly enlarging T2 hyperintense lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The number of new active lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The total number of new T1 hypointense lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The number of Gadolinium (Gd)-enhancing lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The volume of T2 hyperintense lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The volume of T1 hypointense lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • The volume of Gd-enhancing lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • Percent change of whole brain atrophy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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.

  • Time to sustained progression of disability [ Time Frame: 2 years ] [ 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

  • Cognitive function as reflected by the Symbol Digit Modalities Test (SDMT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    SDMT is a screening test for cognitive impairment

  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 physical score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items.

  • Change from Baseline in 12-Item Short Form Health Survey (SF-12) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The SF-12 is a 12-item scale to measure generic health.

  • Change form Baseline in Euro Quality of Life (EQ-5D) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety).

  • The number of relapses requiring intravenous (IV) steroid use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of MS-related hospitalizations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percent of participant-reported treatment satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Participants will complete the Treatment Satisfaction Questionnaire: This questionnaire is composed of a range of questions regarding the participant's perception of treatment satisfaction.


Estimated Enrollment: 1500
Study Start Date: April 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB017 Q2W
125 µg BIIB017 administered by subcutaneous injection every 2 weeks for at least 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).
Other Names:
  • BIIB017
  • PEG IFN β-1a
  • PEGylated Interferon beta-1a
Experimental: BIIB017 Q4W
125 µg BIIB017 administered by subcutaneous injection every 4 weeks (alternate injections with placebo and BIIB017 every 2 weeks) for at least 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).
Other Names:
  • BIIB017
  • PEG IFN β-1a
  • PEGylated Interferon beta-1a
Drug: Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.

Detailed Description:

This is a global, multicenter, parallel-group, dose-frequency blinded study. This study is an extension of Biogen Idec Study 105MS301 (NCT00906399) (ADVANCE) and is designed to evaluate the long-term safety and tolerability of BIIB017, and the long-term effect on multiple sclerosis (MS) outcomes. The study will be conducted at approximately 200 sites.

  Eligibility

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

Key Inclusion Criteria:

  • Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301 (NCT00906399).

Key Exclusion Criteria:

  • Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399).
  • 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.

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: NCT01332019

  Show 157 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01332019     History of Changes
Other Study ID Numbers: 105MS302, 2010-024477-39
Study First Received: March 24, 2011
Last Updated: July 25, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Mexico: Federal Commission for Sanitary Risks Protection
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
Georgia: Ministry of Health
Latvia: State Agency of Medicines
United States: Food and Drug Administration
United Kingdom: Department of Health
New Zealand: Food Safety Authority
Chile: Instituto de Salud Pública de Chile
India: Central Drugs Standard Control Organization
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Romania: Ethics Committee

Keywords provided by Biogen Idec:
Subcutaneous
Extension
Interferon
MS
PEGylated
Injectable
SC
PEG
peginterferon beta-1a
Relapsing

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 1a
Interferon-beta
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 31, 2014