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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 1,077
- Locations
- 1
- Primary Endpoint
- Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301 (NCT00906399).
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.
Arms & Interventions
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.
Intervention: peginterferon beta-1a (Drug)
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.
Intervention: peginterferon beta-1a (Drug)
Outcomes
Primary Outcomes
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 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 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 Outcomes
- Number of New Active Lesions(Week 48, Week 96)
- Number of New T1 Hypointense Lesions(Week 48, Week 96)
- Volume of T2 Hyperintense Lesions(Baseline (start of 105MS302), Week 48, Week 96)
- Percentage Change of Whole Brain Volume(Baseline (start of 105MS302), Week 48, Week 96)
- Number of New or Newly Enlarging T2 Hyperintense Lesions(Week 48, Week 96)
- Annualized Relapse Rate (ARR)(up to 4 years)
- Percentage of Participants Who Relapsed(Up to 4 years)
- Number of Gd-Enhancing Lesions(Baseline (start of 105MS302), Week 48, Week 96)
- Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections(Year 1, Year 2, Year 3)
- Volume of T1 Hypointense Lesions(Baseline (start of 105MS302), Week 48, Week 96)
- Change From Baseline in Symbol Digit Modalities Test (SDMT)(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Volume of Gd-Enhancing Lesions(Baseline (start of 105MS302), Week 48, Week 96)
- Time to Sustained Disability Progression(Weeks 12, 24, 28, 72, 96, 120, 144, 168)
- Change From Baseline in Expanded Disability Status Scale (EDSS)(Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168)
- Change From Baseline in SF-12 Physical Component Score (PCS)(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Change From Baseline in Euro Quality of Life (EQ-5D) Index Score(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Change From Baseline in EQ-5D Visual Analogue Scale (VAS)(Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168)
- Number of Relapses Requiring IV Steroid Use(up to 4 years)
- Number of MS-Related Hospitalizations(up to 4 years)
- Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.(Year 1, Year 2, Year 3)
- Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.(Year 1, Year 2, Year 3)