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Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB033
Placebo
Avonex
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
  • RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
  • All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment

Key Exclusion Criteria:

  • A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
  • Previous history of clinically significant disease.
  • Plans to undergo elective major procedures/surgeries at any time during the study.
  • Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
  • RRMS subjects with any history of inadequate response to any approved interferon β preparation
  • History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
  • History or evidence of drug or alcohol abuse within 2 years prior to randomization

Note: Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

  • North Central Neurology Assoc PC
  • Phoenix Neurological Associates
  • Raleigh Neurology Associates PA
  • Stanford University Medical Center
  • Immunoe International Research Center
  • Johns Hopkins Hospital
  • Michigan Institute For Neurological Disorders
  • Washington University
  • Multiple Sclerosis Center of North Eastern New York
  • OMRF Multiple Sclerosis Center of Excellence
  • Swedish Medical Center
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • London Health Sciences Centre
  • Vseobecna Fakultni Nemocnice V Praze
  • Fakultni Nemocnice Hradec Kralove
  • Nemocnice Jihlava Prispevkova Organizace
  • NEUROSPOL Sro
  • Fakultni nemocnice v Motole
  • Krajska Zdravotni a.s. Nemocnice Teplice Oz
  • Hôpital Guillaume Et René Laënnec
  • Hôpital Maison Blanche
  • Hôpital Roger Salengro
  • Hôpital Sud
  • Hopital Gabriel Montpied
  • CHRU Nancy
  • Fondation Rothschild
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Uzsoki Utcai Korhaz
  • Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
  • Pécsi Tudományegyetem
  • Azienda Ospedaliera Universitaria San Martino
  • Ospedale San Raffaele S.r.l.
  • Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
  • Fondazione Istituto San Raffaele G. Giglio di Cefalù
  • Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
  • Azienda Ospedaliera S. Antonio Abate di Gallarate
  • Erasmus MC
  • Zuyderland Medisch Centrum
  • Centrum Neurologii K. Selmaj
  • Wojskowy Instytut Medyczny
  • Novo-Med Zielinski i wsp. Sp.J.
  • Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
  • M.A.- Lek A.M.Maciejowscy Spolka Cywilna
  • Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
  • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
  • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
  • SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
  • EUROMEDIS Sp. z o.o.
  • Kaluga Regional Hospital
  • Republican Clinical Hospital For Rehabilitation Treatment
  • Krasnoyarsk State Medical Academy
  • Perm State Medical Academy
  • City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
  • Regional Clinical Hospital #3
  • Clinical Center of Serbia
  • Military Medical Academy
  • Clinical Center Kragujevac
  • General Hospital Uzice
  • Hospital Universitari de Bellvitge
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario Reina Sofia
  • Hospital Clinico San Carlos
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital de Basurto Osakidetza
  • Hospital General Carlos Haya
  • Hospital Universitario Virgen Macarena
  • Queen's Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BIIB033, 3 mg/kg

BIIB033, 10 mg/kg

BIIB033, 30 mg/kg

BIIB033, 100 mg/kg

Placebo

Arm Description

BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84.

BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Outcomes

Primary Outcome Measures

Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.

Secondary Outcome Measures

Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; 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 Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84

Full Information

First Posted
May 24, 2013
Last Updated
March 23, 2017
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01864148
Brief Title
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Acronym
SYNERGY
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (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 the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB033, 3 mg/kg
Arm Type
Experimental
Arm Description
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84.
Arm Title
BIIB033, 10 mg/kg
Arm Type
Experimental
Arm Description
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Arm Title
BIIB033, 30 mg/kg
Arm Type
Experimental
Arm Description
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Arm Title
BIIB033, 100 mg/kg
Arm Type
Experimental
Arm Description
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention Type
Drug
Intervention Name(s)
BIIB033
Other Intervention Name(s)
anti-LINGO-1 mAb
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Avonex
Other Intervention Name(s)
interferon beta-1a
Primary Outcome Measure Information:
Title
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Description
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
Description
Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.
Time Frame
72 weeks
Title
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Description
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; 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 Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.
Time Frame
Up to 84 weeks
Title
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Time Frame
Up to 84 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS) RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment. All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment Key Exclusion Criteria: A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening Previous history of clinically significant disease. Plans to undergo elective major procedures/surgeries at any time during the study. Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline RRMS subjects with any history of inadequate response to any approved interferon β preparation History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus History or evidence of drug or alcohol abuse within 2 years prior to randomization 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
North Central Neurology Assoc PC
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Phoenix Neurological Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Raleigh Neurology Associates PA
City
Raleigh
State/Province
California
ZIP/Postal Code
27607-6000
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Immunoe International Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Michigan Institute For Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Multiple Sclerosis Center of North Eastern New York
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
OMRF Multiple Sclerosis Center of Excellence
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Research Site
City
Ottowa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Gatinueau
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
London Health Sciences Centre
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Praha
State/Province
Hlavní Mesto
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Králové
State/Province
Královéhradecký kraj
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Nemocnice Jihlava Prispevkova Organizace
City
Jihlava
State/Province
Vysocina
ZIP/Postal Code
586 33
Country
Czech Republic
Facility Name
NEUROSPOL Sro
City
Havirov
ZIP/Postal Code
736 01
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Krajska Zdravotni a.s. Nemocnice Teplice Oz
City
Teplice
State/Province
Ústecký kraj
ZIP/Postal Code
415 29
Country
Czech Republic
Facility Name
Hôpital Guillaume Et René Laënnec
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Maison Blanche
City
Reims
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Sud
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
Country
Italy
Facility Name
Fondazione Istituto San Raffaele G. Giglio di Cefalù
City
Cefalù
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliera S. Antonio Abate di Gallarate
City
Gallarate
State/Province
Varese
ZIP/Postal Code
21013
Country
Italy
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Centrum Neurologii K. Selmaj
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
93-121
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-901
Country
Poland
Facility Name
Novo-Med Zielinski i wsp. Sp.J.
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-650
Country
Poland
Facility Name
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
EUROMEDIS Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Kaluga Regional Hospital
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Republican Clinical Hospital For Rehabilitation Treatment
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
Perm State Medical Academy
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Regional Clinical Hospital #3
City
Volgograd
ZIP/Postal Code
400001
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Uzice
City
Uzice
ZIP/Postal Code
31000
Country
Serbia
Facility Name
Hospital Universitari de Bellvitge
City
l Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
14008
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
State/Province
Madrid, Communidad Delaware
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital de Basurto Osakidetza
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital General Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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31285147
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Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

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