Back to resultsEfficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis (ADVANCE)
Primary Purpose
Relapsing Multiple Sclerosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BIIB017 (peginterferon beta-1a)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring interferon, injectable, MS, SC, PEGylated, Interferon beta-1a, relapsing, PEG, multiple sclerosis, subcutaneous
Eligibility Criteria
Key Inclusion Criteria:
- Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
- Must have an EDSS score between 0.0 and 5.0.
- Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Key Exclusion Criteria:
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
- Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Peginterferon Beta-1a Q2W
Peginterferon Beta-1a Q4W
Arm Description
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Outcomes
Primary Outcome Measures
Annualized Relapse Rate (ARR) at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
Secondary Outcome Measures
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year
Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
Proportion of Participants Relapsed at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year
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 MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00906399
Brief Title
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Acronym
ADVANCE
Official Title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
Detailed Description
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
interferon, injectable, MS, SC, PEGylated, Interferon beta-1a, relapsing, PEG, multiple sclerosis, subcutaneous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
Arm Title
Peginterferon Beta-1a Q2W
Arm Type
Experimental
Arm Description
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
Arm Title
Peginterferon Beta-1a Q4W
Arm Type
Experimental
Arm Description
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Intervention Type
Drug
Intervention Name(s)
BIIB017 (peginterferon beta-1a)
Other Intervention Name(s)
PEG IFN ß-1a, PEGylated interferon beta-1a, Plegridy
Intervention Description
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR) at 1 Year
Description
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year
Description
Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
Time Frame
1 Year
Title
Proportion of Participants Relapsed at 1 Year
Description
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
Time Frame
Year 1
Title
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year
Description
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 MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
Must have an EDSS score between 0.0 and 5.0.
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Key Exclusion Criteria:
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women
Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Ponte Vedra Beach
State/Province
Florida
ZIP/Postal Code
32082 4040
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Research Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607 6520
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Research Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Research Site
City
'Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Research Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Research Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Research Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Research Site
City
Ostrava - Vitkovice
ZIP/Postal Code
70200
Country
Czech Republic
Facility Name
Research Site
City
Ostrava-Poruba
ZIP/Postal Code
70300
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
41529
Country
Czech Republic
Facility Name
Research Site
City
Parnu
ZIP/Postal Code
EE 80010
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
EE 10617
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
EE 51014
Country
Estonia
Facility Name
Research Site
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Research Site
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
6002
Country
France
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
141
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
179
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Facility Name
Research Site
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Research Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Research Site
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Research Site
City
Koln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
Munchen
ZIP/Postal Code
80331
Country
Germany
Facility Name
Research Site
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Prien
ZIP/Postal Code
83209
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89079
Country
Germany
Facility Name
Research Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Research Site
City
Saket
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Research Site
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360001
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Research Site
City
Indore
State/Province
Madhyr Pradesh
ZIP/Postal Code
452018
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Research Site
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Research Site
City
Amritsar
State/Province
Punjab
ZIP/Postal Code
143001
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Research Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600017
Country
India
Facility Name
Research Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
Facility Name
Research Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700068
Country
India
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560017
Country
India
Facility Name
Research Site
City
Mangalore
ZIP/Postal Code
575018
Country
India
Facility Name
Research Site
City
Navi Mumbai
ZIP/Postal Code
400703
Country
India
Facility Name
Research Site
City
Nehru Nagar
ZIP/Postal Code
110065
Country
India
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV 1005
Country
Latvia
Facility Name
Research Site
City
Aquas Calientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
10700
Country
Mexico
Facility Name
Research Site
City
Mexico DF
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Research Site
City
Monterrey, Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Research Site
City
Tijuana, Baja California
ZIP/Postal Code
22320
Country
Mexico
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818CK
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Christchurch
Country
New Zealand
Facility Name
Research Site
City
Dunedin
Country
New Zealand
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 21
Country
Peru
Facility Name
Research Site
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15276
Country
Poland
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15402
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85681
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80299
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80803
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40650
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40662
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40684
Country
Poland
Facility Name
Research Site
City
Konskie
ZIP/Postal Code
26200
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31505
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31637
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31826
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90153
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20718
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20954
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10082
Country
Poland
Facility Name
Research Site
City
Plewiska
ZIP/Postal Code
62064
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60355
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61853
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70215
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71252
Country
Poland
Facility Name
Research Site
City
Warsawa
ZIP/Postal Code
00851
Country
Poland
Facility Name
Research Site
City
Warsawa
ZIP/Postal Code
02957
Country
Poland
Facility Name
Research Site
City
Warsawa
ZIP/Postal Code
04141
Country
Poland
Facility Name
Research Site
City
Warsawa
ZIP/Postal Code
04749
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50556
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41800
Country
Poland
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
50098
Country
Romania
Facility Name
Research Site
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700656
Country
Romania
Facility Name
Research Site
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
Research Site
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
Research Site
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
Research Site
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Research Site
City
Rostov-on-Don
ZIP/Postal Code
344015
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Research Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14008
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58018
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Research Site
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
3110
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
4107
Country
Ukraine
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Research Site
City
Poltava
ZIP/Postal Code
26011
Country
Ukraine
Facility Name
Research Site
City
Simferopol
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
Research Site
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Research Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24794721
Citation
Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.
Results Reference
result
PubMed Identifier
33307998
Citation
Calabresi PA, Arnold DL, Sangurdekar D, Singh CM, Altincatal A, de Moor C, Engle B, Goyal J, Deykin A, Szak S, Kieseier BC, Rudick RA, Plavina T. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021 Sep;27(10):1497-1505. doi: 10.1177/1352458520972573. Epub 2020 Dec 14.
Results Reference
derived
PubMed Identifier
29104758
Citation
Cleanthous S, Cano S, Kinter E, Marquis P, Petrillo J, You X, Wakeford C, Sabatella G. Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT). Mult Scler J Exp Transl Clin. 2017 Aug 15;3(3):2055217317725917. doi: 10.1177/2055217317725917. eCollection 2017 Jul-Sep.
Results Reference
derived
PubMed Identifier
28607743
Citation
Scott TF, Kieseier BC, Newsome SD, Arnold DL, You X, Hung S, Sperling B. Improvement in relapse recovery with peginterferon beta-1a in patients with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316676644. doi: 10.1177/2055217316676644. eCollection 2016 Jan-Dec.
Results Reference
derived
PubMed Identifier
28450894
Citation
Newsome SD, Kieseier BC, Liu S, You X, Kinter E, Hung S, Sperling B. Peginterferon beta-1a reduces disability worsening in relapsing-remitting multiple sclerosis: 2-year results from ADVANCE. Ther Adv Neurol Disord. 2017 Jan;10(1):41-50. doi: 10.1177/1756285616676065. Epub 2016 Nov 16.
Results Reference
derived
PubMed Identifier
28183276
Citation
Arnold DL, Calabresi PA, Kieseier BC, Liu S, You X, Fiore D, Hung S. Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial. BMC Neurol. 2017 Feb 10;17(1):29. doi: 10.1186/s12883-017-0799-0.
Results Reference
derived
PubMed Identifier
26195056
Citation
Newsome SD, Guo S, Altincatal A, Proskorovsky I, Kinter E, Phillips G, You X, Sabatella G. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.
Results Reference
derived
PubMed Identifier
25551571
Citation
Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S. Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis. BMC Neurol. 2014 Dec 31;14:240. doi: 10.1186/s12883-014-0240-x.
Results Reference
derived
PubMed Identifier
25432952
Citation
Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.
Results Reference
derived
PubMed Identifier
25265472
Citation
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S. Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study. Br J Clin Pharmacol. 2015 Mar;79(3):514-22. doi: 10.1111/bcp.12521.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
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