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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01332019




Registration number
NCT01332019
Ethics application status
Date submitted
24/03/2011
Date registered
8/04/2011
Date last updated
13/01/2017

Titles & IDs
Public title
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
Scientific 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
Secondary ID [1] 0 0
2010-024477-39
Secondary ID [2] 0 0
105MS302
Universal Trial Number (UTN)
Trial acronym
ATTAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - peginterferon beta-1a

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.

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.


Treatment: Drugs: peginterferon beta-1a
Administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs
Timepoint [1] 0 0
up to 4 years
Primary outcome [2] 0 0
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Timepoint [2] 0 0
up to 4 years
Primary outcome [3] 0 0
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values
Timepoint [3] 0 0
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
Primary outcome [4] 0 0
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry
Timepoint [4] 0 0
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
Primary outcome [5] 0 0
Number of Participants With Shifts From Baseline: Urinalysis
Timepoint [5] 0 0
Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years
Secondary outcome [1] 0 0
Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
up to 4 years
Secondary outcome [2] 0 0
Percentage of Participants Who Relapsed
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Number of New or Newly Enlarging T2 Hyperintense Lesions
Timepoint [3] 0 0
Week 48, Week 96
Secondary outcome [4] 0 0
Number of New Active Lesions
Timepoint [4] 0 0
Week 48, Week 96
Secondary outcome [5] 0 0
Number of New T1 Hypointense Lesions
Timepoint [5] 0 0
Week 48, Week 96
Secondary outcome [6] 0 0
Number of Gd-Enhancing Lesions
Timepoint [6] 0 0
Baseline (start of 105MS302), Week 48, Week 96
Secondary outcome [7] 0 0
Volume of T2 Hyperintense Lesions
Timepoint [7] 0 0
Baseline (start of 105MS302), Week 48, Week 96
Secondary outcome [8] 0 0
Volume of T1 Hypointense Lesions
Timepoint [8] 0 0
Baseline (start of 105MS302), Week 48, Week 96
Secondary outcome [9] 0 0
Volume of Gd-Enhancing Lesions
Timepoint [9] 0 0
Baseline (start of 105MS302), Week 48, Week 96
Secondary outcome [10] 0 0
Percentage Change of Whole Brain Volume
Timepoint [10] 0 0
Baseline (start of 105MS302), Week 48, Week 96
Secondary outcome [11] 0 0
Change From Baseline in Expanded Disability Status Scale (EDSS)
Timepoint [11] 0 0
Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168
Secondary outcome [12] 0 0
Time to Sustained Disability Progression
Timepoint [12] 0 0
Weeks 12, 24, 28, 72, 96, 120, 144, 168
Secondary outcome [13] 0 0
Change From Baseline in Symbol Digit Modalities Test (SDMT)
Timepoint [13] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [14] 0 0
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score
Timepoint [14] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [15] 0 0
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)
Timepoint [15] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [16] 0 0
Change From Baseline in SF-12 Physical Component Score (PCS)
Timepoint [16] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [17] 0 0
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score
Timepoint [17] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [18] 0 0
Change From Baseline in EQ-5D Visual Analogue Scale (VAS)
Timepoint [18] 0 0
Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168
Secondary outcome [19] 0 0
Number of Relapses Requiring IV Steroid Use
Timepoint [19] 0 0
up to 4 years
Secondary outcome [20] 0 0
Number of MS-Related Hospitalizations
Timepoint [20] 0 0
up to 4 years
Secondary outcome [21] 0 0
Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?
Timepoint [21] 0 0
Year 1, Year 2, Year 3
Secondary outcome [22] 0 0
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?
Timepoint [22] 0 0
Year 1, Year 2, Year 3
Secondary outcome [23] 0 0
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?
Timepoint [23] 0 0
Year 1, Year 2, Year 3
Secondary outcome [24] 0 0
Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?
Timepoint [24] 0 0
Year 1, Year 2, Year 3
Secondary outcome [25] 0 0
Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?
Timepoint [25] 0 0
Year 1, Year 2, Year 3
Secondary outcome [26] 0 0
Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?
Timepoint [26] 0 0
Year 1, Year 2, Year 3
Secondary outcome [27] 0 0
Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.
Timepoint [27] 0 0
Year 1, Year 2, Year 3
Secondary outcome [28] 0 0
Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.
Timepoint [28] 0 0
Year 1, Year 2, Year 3
Secondary outcome [29] 0 0
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.
Timepoint [29] 0 0
Year 1, Year 2, Year 3
Secondary outcome [30] 0 0
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.
Timepoint [30] 0 0
Year 1, Year 2, Year 3
Secondary outcome [31] 0 0
Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.
Timepoint [31] 0 0
Year 1, Year 2, Year 3
Secondary outcome [32] 0 0
Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.
Timepoint [32] 0 0
Year 1, Year 2, Year 3
Secondary outcome [33] 0 0
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?
Timepoint [33] 0 0
Year 1, Year 2, Year 3
Secondary outcome [34] 0 0
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections
Timepoint [34] 0 0
Year 1, Year 2, Year 3

Eligibility
Key inclusion criteria
Key

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

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
1077
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
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United States of America
State/province [2] 0 0
Kentucky
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United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
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North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
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United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
Belgium
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Sint-Truiden
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Bulgaria
State/province [8] 0 0
Plovdiv
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Bulgaria
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Sofia
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Canada
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Ontario
Country [11] 0 0
Canada
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Quebec
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Chile
State/province [12] 0 0
Santiago
Country [13] 0 0
Colombia
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Barranquilla
Country [14] 0 0
Colombia
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Bogota
Country [15] 0 0
Croatia
State/province [15] 0 0
Zagreb
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Brno
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Havffov
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Ostrava-Vitkovice
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Ostrava
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Praha 5
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Praha
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Teplice
Country [24] 0 0
Estonia
State/province [24] 0 0
Parnu
Country [25] 0 0
Estonia
State/province [25] 0 0
Tallinn
Country [26] 0 0
Estonia
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Tartu
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France
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Amiens
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France
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Bouches-du-Rhone
Country [29] 0 0
France
State/province [29] 0 0
Clermont-Ferrand
Country [30] 0 0
France
State/province [30] 0 0
Nice
Country [31] 0 0
Georgia
State/province [31] 0 0
Tbilisi
Country [32] 0 0
Germany
State/province [32] 0 0
Bayreuth
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
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Erbach
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Germany
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Hannover
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Germany
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Koln
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Germany
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Leipzig
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Germany
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Marberg
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Germany
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Prien
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Germany
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Ulm
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Germany
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Westerstede
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Greece
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Athens
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Greece
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Thessaloniki
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India
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Gujarat
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India
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Madhyr Pradesh
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India
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Maharashtra
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India
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Punjab
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India
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Tamil Nadu
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India
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West Bengal
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India
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Bangalore
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India
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Chennai
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India
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Mangalore
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India
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Navi Mumbai
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India
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New Delhi
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India
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Saket
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Latvia
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Riga
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
Country [59] 0 0
Mexico
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Heroes de Padierna
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico City
Country [61] 0 0
Mexico
State/province [61] 0 0
Monterrey
Country [62] 0 0
Netherlands
State/province [62] 0 0
Breda
Country [63] 0 0
Netherlands
State/province [63] 0 0
Nieuwegein
Country [64] 0 0
New Zealand
State/province [64] 0 0
Auckland
Country [65] 0 0
New Zealand
State/province [65] 0 0
Christchurch
Country [66] 0 0
New Zealand
State/province [66] 0 0
Dunedin
Country [67] 0 0
Peru
State/province [67] 0 0
Lima
Country [68] 0 0
Peru
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San Isidro
Country [69] 0 0
Poland
State/province [69] 0 0
Bialystok
Country [70] 0 0
Poland
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Bydgoszcz
Country [71] 0 0
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Gdansk
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Katowice
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Konskie
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Krakow
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Lodz
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Lublin
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Poland
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Olsztyn
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Poland
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Plewiska
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
Country [82] 0 0
Poland
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Wroclaw
Country [83] 0 0
Romania
State/province [83] 0 0
Brasov
Country [84] 0 0
Romania
State/province [84] 0 0
Bucharest
Country [85] 0 0
Romania
State/province [85] 0 0
Campulung
Country [86] 0 0
Romania
State/province [86] 0 0
Sibiu
Country [87] 0 0
Romania
State/province [87] 0 0
Targu Mures
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Kaluga
Country [89] 0 0
Russian Federation
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Kazan
Country [90] 0 0
Russian Federation
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Kransodar
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Perm
Country [95] 0 0
Russian Federation
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Rostov-on-Don
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Smolensk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Ufa
Country [98] 0 0
Serbia
State/province [98] 0 0
Belgrade
Country [99] 0 0
Serbia
State/province [99] 0 0
Kragujevac
Country [100] 0 0
Serbia
State/province [100] 0 0
Nis
Country [101] 0 0
Spain
State/province [101] 0 0
Cordoba
Country [102] 0 0
Spain
State/province [102] 0 0
Madrid
Country [103] 0 0
Spain
State/province [103] 0 0
Malaga
Country [104] 0 0
Spain
State/province [104] 0 0
Seville
Country [105] 0 0
Ukraine
State/province [105] 0 0
Chernivtsi
Country [106] 0 0
Ukraine
State/province [106] 0 0
Dnipropetrovsk
Country [107] 0 0
Ukraine
State/province [107] 0 0
Donetsk
Country [108] 0 0
Ukraine
State/province [108] 0 0
Kharkiv
Country [109] 0 0
Ukraine
State/province [109] 0 0
Kyiv
Country [110] 0 0
Ukraine
State/province [110] 0 0
Odesa
Country [111] 0 0
Ukraine
State/province [111] 0 0
Poltava
Country [112] 0 0
Ukraine
State/province [112] 0 0
Simferopol
Country [113] 0 0
Ukraine
State/province [113] 0 0
Ternopil
Country [114] 0 0
Ukraine
State/province [114] 0 0
Vinnytsya
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Manchester
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Nottingham
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01332019
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01332019