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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332019
First Posted: April 8, 2011
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 (AEs) Serious AEs, and Discontinuations Due to AEs [ Time Frame: up to 4 years ]
    AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

  • Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities [ Time Frame: up to 4 years ]
    Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

  • Number of Participants With Shifts From Baseline: Liver Function Laboratory Values [ Time Frame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years ]
    Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.

  • Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry [ Time Frame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years ]
    Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.

  • Number of Participants With Shifts From Baseline: Urinalysis [ Time Frame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years ]
    Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.


Secondary Outcome Measures:
  • Annualized Relapse Rate (ARR) [ Time Frame: up to 4 years ]
    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 annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.

  • Percentage of Participants Who Relapsed [ Time Frame: Up to 4 years ]
    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 were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.

  • Number of New or Newly Enlarging T2 Hyperintense Lesions [ Time Frame: Week 48, Week 96 ]
    The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Number of New Active Lesions [ Time Frame: Week 48, Week 96 ]
    The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Number of New T1 Hypointense Lesions [ Time Frame: Week 48, Week 96 ]
    The total number of new T1 hypointense lesions as assessed by MRI.

  • Number of Gd-Enhancing Lesions [ Time Frame: Baseline (start of 105MS302), Week 48, Week 96 ]
    The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Volume of T2 Hyperintense Lesions [ Time Frame: Baseline (start of 105MS302), Week 48, Week 96 ]
    The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Volume of T1 Hypointense Lesions [ Time Frame: Baseline (start of 105MS302), Week 48, Week 96 ]
    The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Volume of Gd-Enhancing Lesions [ Time Frame: Baseline (start of 105MS302), Week 48, Week 96 ]
    The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Percentage Change of Whole Brain Volume [ Time Frame: Baseline (start of 105MS302), Week 48, Week 96 ]
    Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Change From Baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168 ]
    Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). 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. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Time to Sustained Disability Progression [ Time Frame: Weeks 12, 24, 28, 72, 96, 120, 144, 168 ]
    Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 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. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.

  • Change From Baseline in Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    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 (worst) to 110 (best).

  • Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    The 29-item MSIS-29 is a disease-specific participant-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. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    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. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Change From Baseline in SF-12 Physical Component Score (PCS) [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    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. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Change From Baseline in Euro Quality of Life (EQ-5D) Index Score [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant's Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Change From Baseline in EQ-5D Visual Analogue Scale (VAS) [ Time Frame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 ]
    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Number of Relapses Requiring IV Steroid Use [ Time Frame: up to 4 years ]
    Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Number of MS-Related Hospitalizations [ Time Frame: up to 4 years ]
    Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How tolerable or intolerable do you find the medication?" answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How convenient or inconvenient is it to take your medication as instructed?" answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How convenient or inconvenient is it to take your medication every 2 weeks?" answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Overall, how satisfied or dissatisfied are you with this medication?" answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)?" answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How likely would you be to continue to use this medication?" answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family)," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "The twice a month dosing makes it more convenient for me to travel/vacation," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "The twice a month dosing enables me to be more spontaneous and flexible," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This medication improves my self-confidence and self-reliance," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "I am satisfied with the dosing frequency (2 times per month) of this medication" answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Over the past 4 weeks, did you miss any of your injections?" answer choices were given as "none missed," "miss 1 injection," or "miss 2 injections." Data after Amendment 3 took effect are excluded.

  • Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections [ Time Frame: Year 1, Year 2, Year 3 ]
    Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Main reason for missed injections?" answer choices were given as "medication side effects," "injection pain," "forget to take medication," "tired of taking injections," "don't think medication is working," or "other." Data after Amendment 3 took effect are excluded.


Enrollment: 1077
Study Start Date: April 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peginterferon beta-1a Q4W
125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 4 weeks (Q4W) for at least 2 years and up to 4 years.
Drug: peginterferon beta-1a
Administered as specified in the treatment arm
Other Names:
  • PEGylated Interferon beta-1a
  • Plegridy
  • PEG IFN β-1a
  • BIIB017
Experimental: peginterferon beta-1a Q2W
125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 laboratory 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332019


  Show 151 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

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 ( EudraCT Number )
First Submitted: March 24, 2011
First Posted: April 8, 2011
Results First Submitted: September 28, 2016
Results First Posted: January 13, 2017
Last Update Posted: January 13, 2017
Last Verified: November 2016

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

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