Long-Term Safety and Efficacy Study of Peginterferon Beta-1a (ATTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01332019
First received: March 24, 2011
Last updated: June 25, 2015
Last verified: June 2015
  Purpose

The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a 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 peginterferon beta-1a treatment.


Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: peginterferon beta-1a
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:

Primary Outcome Measures:
  • Number of participants experiencing adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing serious adverse events [ 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 ]
    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 as assessed by magnetic resonance imaging (MRI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of new active lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The total number of new T1 hypointense lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of Gadolinium (Gd)-enhancing lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The volume of T2 hyperintense lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The volume of T1 hypointense lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The volume of Gd-enhancing lesions as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Percent change of whole brain atrophy as assessed by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 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. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).

  • 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 multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of 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: peginterferon beta-1a Q2W
125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 2 weeks (Q2W) for at least 2 years and up to 4.5 years.
Drug: peginterferon beta-1a
Administered as specified in the treatment arm
Other Names:
  • PEGylated Interferon beta-1a
  • Plegridy
  • PEG IFN β-1a
  • BIIB017

  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 153 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided by Biogen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01332019     History of Changes
Other Study ID Numbers: 105MS302, 2010-024477-39
Study First Received: March 24, 2011
Last Updated: June 25, 2015
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:
Subcutaneous
Extension
Interferon
MS
PEGylated
Injectable
SC
PEG
peginterferon beta-1a
Relapsing

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015