Clinical trial NCT01332019: Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: Subcutaneous
Extension
Interferon
MS
PEGylated
Injectable
SC
PEG
peginterferon beta-1a
Relapsing
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs
timeFrame: up to 4 years
measure: Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
timeFrame: up to 4 years
measure: Number of Participants With Shifts From Baseline: Liver Function Laboratory Values
timeFrame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
measure: Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry
timeFrame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
measure: Number of Participants With Shifts From Baseline: Urinalysis
timeFrame: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
Secondary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: up to 4 years
measure: Percentage of Participants Who Relapsed
timeFrame: Up to 4 years
measure: Number of New or Newly Enlarging T2 Hyperintense Lesions
timeFrame: Week 48, Week 96
measure: Number of New Active Lesions
timeFrame: Week 48, Week 96
measure: Number of New T1 Hypointense Lesions
timeFrame: Week 48, Week 96
measure: Number of Gd-Enhancing Lesions
timeFrame: Baseline (start of 105MS302), Week 48, Week 96
measure: Volume of T2 Hyperintense Lesions
timeFrame: Baseline (start of 105MS302), Week 48, Week 96
measure: Volume of T1 Hypointense Lesions
timeFrame: Baseline (start of 105MS302), Week 48, Week 96
measure: Volume of Gd-Enhancing Lesions
timeFrame: Baseline (start of 105MS302), Week 48, Week 96
measure: Percentage Change of Whole Brain Volume
timeFrame: Baseline (start of 105MS302), Week 48, Week 96
measure: Change From Baseline in Expanded Disability Status Scale (EDSS)
timeFrame: Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168
measure: Time to Sustained Disability Progression
timeFrame: Weeks 12, 24, 28, 72, 96, 120, 144, 168
measure: Change From Baseline in Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Change From Baseline in SF-12 Physical Component Score (PCS)
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Change From Baseline in Euro Quality of Life (EQ-5D) Index Score
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS)
timeFrame: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
measure: Number of Relapses Requiring IV Steroid Use
timeFrame: up to 4 years
measure: Number of MS-Related Hospitalizations
timeFrame: up to 4 years
measure: Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?
timeFrame: Year 1, Year 2, Year 3
measure: Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections
timeFrame: Year 1, Year 2, Year 3
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
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state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Sint-Truiden
country: Belgium
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: London
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Santiago
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Havffov
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Ostrava-Vitkovice
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Teplice
country: Czech Republic
facility: Research Site
city: Parnu
country: Estonia
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Bouches-du-Rhone
country: France
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city: Clermont-Ferrand
country: France
facility: Research Site
city: Nice
country: France
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city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Berlin
country: Germany
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city: Erbach
country: Germany
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city: Hannover
country: Germany
facility: Research Site
city: Koln
country: Germany
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city: Leipzig
country: Germany
facility: Research Site
city: Marberg
country: Germany
facility: Research Site
city: Prien
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Athens
country: Greece
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city: Athens
country: Greece
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city: Thessaloniki
country: Greece
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city: Ahmedabad
country: India
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state: Gujarat
city: Rajkot
country: India
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state: Gujarat
city: Indore
country: India
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state: Madhyr Pradesh
city: Mumbai
country: India
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state: Maharashtra
city: Nagpur
country: India
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state: Maharashtra
city: Pune
country: India
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state: Maharashtra
city: Pune
country: India
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city: Amritsar
country: India
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state: Punjab
city: Coimbatore
country: India
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state: Tamil Nadu
city: Kolkata
country: India
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state: West Bengal
city: Bangalore
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Mangalore
country: India
facility: Research Site
city: Navi Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
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city: New Delhi
country: India
facility: Research Site
city: Saket
country: India
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Heroes de Padierna
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Auckland
country: New Zealand
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city: Christchurch
country: New Zealand
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country: New Zealand
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country: Peru
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country: Peru
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country: Peru
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city: San Isidro
country: Peru
facility: Research Site
city: Bialystok
country: Poland
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city: Bialystok
country: Poland
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city: Bydgoszcz
country: Poland
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city: Gdansk
country: Poland
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city: Gdansk
country: Poland
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city: Gdansk
country: Poland
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city: Katowice
country: Poland
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city: Katowice
country: Poland
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city: Katowice
country: Poland
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city: Katowice
country: Poland
facility: Research Site
city: Konskie
country: Poland
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city: Krakow
country: Poland
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city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
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city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Plewiska
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Campulung
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kransodar
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Seville
country: Spain
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Vinnytsya
country: Ukraine
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Arnold DL, Shang S, Dong Q, Meergans M, Naylor ML. Peginterferon beta-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418795085. doi: 10.1177/1756286418795085. eCollection 2018.
citation: Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA. Single-use autoinjector for peginterferon-beta1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 10.1517/17425247.2014.944159. Epub 2014 Jul 29.