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
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
2 other identifiers
interventional
419
12 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started Aug 2013
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
May 3, 2017
CompletedMay 3, 2017
March 1, 2017
2.3 years
May 24, 2013
March 23, 2017
March 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
72 weeks
Secondary Outcomes (3)
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
72 weeks
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Up to 84 weeks
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Up to 84 weeks
Study Arms (5)
BIIB033, 3 mg/kg
EXPERIMENTALBIIB033 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
EXPERIMENTALBIIB033 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
EXPERIMENTALBIIB033 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
EXPERIMENTALBIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Placebo
PLACEBO COMPARATORPlacebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (72)
North Central Neurology Assoc PC
Cullman, Alabama, 35058, United States
Phoenix Neurological Associates
Phoenix, Arizona, 85018, United States
Raleigh Neurology Associates PA
Raleigh, California, 27607-6000, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Immunoe International Research Center
Centennial, Colorado, 80112, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, 48334, United States
Washington University
St Louis, Missouri, 63110, United States
Multiple Sclerosis Center of North Eastern New York
Latham, New York, 12110, United States
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, 73104, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Research Site
Ottowa, Ontario, Canada
Research Site
Gatinueau, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Lévis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
London Health Sciences Centre
London, N6A 5A5, Canada
Vseobecna Fakultni Nemocnice V Praze
Prague, Hlavní Mesto, 128 08, Czechia
Nemocnice Jihlava Prispevkova Organizace
Jihlava, Kraj Vysočina, 586 33, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Královéhradecký kraj, 500 05, Czechia
NEUROSPOL Sro
Havířov, 736 01, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Krajska Zdravotni a.s. Nemocnice Teplice Oz
Teplice, Ústecký kraj, 415 29, Czechia
Hôpital Guillaume Et René Laënnec
Nantes, Loire-Atlantique, 44805, France
Hôpital Maison Blanche
Reims, Marne, 51092, France
Hôpital Roger Salengro
Lille, Nord, 59000, France
Hôpital Sud
Amiens, Somme, 80054, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
CHRU Nancy
Nancy, 54000, France
Fondation Rothschild
Paris, 75019, France
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6725, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
Budapest, 1204, Hungary
Pécsi Tudományegyetem
Pécs, 7623, Hungary
Azienda Ospedaliera Universitaria San Martino
Genoa, Liguria, 16132, Italy
Ospedale San Raffaele S.r.l.
Milan, Lombardy, 20127, Italy
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
Montichiari, Lombardy, 25018, Italy
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, 90015, Italy
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
Catania, Sicily, 95123, Italy
Azienda Ospedaliera S. Antonio Abate di Gallarate
Gallarate, Varese, 21013, Italy
Erasmus MC
Rotterdam, South Holland, 3015 CE, Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen, 6162 BG, Netherlands
Centrum Neurologii K. Selmaj
Lódz, Lódzkie, 93-121, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, 00-901, Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Silesian Voivodeship, 40-650, Poland
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, 80-803, Poland
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziądz, 86-300, Poland
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
Katowice, 40-595, Poland
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
Katowice, 40-749, Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
Plewiska, 62-064, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, 61-853, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
Rybnik, 44-200, Poland
EUROMEDIS Sp. z o.o.
Szczecin, 70-215, Poland
Kaluga Regional Hospital
Kaluga, 248007, Russia
Republican Clinical Hospital For Rehabilitation Treatment
Kazan', 420021, Russia
Krasnoyarsk State Medical Academy
Krasnoyarsk, 660049, Russia
Perm State Medical Academy
Perm, 614990, Russia
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Saint Petersburg, 197110, Russia
Regional Clinical Hospital #3
Volgograd, 400001, Russia
Clinical Center of Serbia
Belgrade, Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
General Hospital Uzice
Užice, 31000, Serbia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 8035, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, 14008, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Communidad Delaware, 28040, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071, Spain
Hospital de Basurto Osakidetza
Bilbao, Vizcaya, 48013, Spain
Hospital General Carlos Haya
Málaga, 29010, Spain
Queen's Medical Centre
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (2)
Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
PMID: 31285147DERIVEDWilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
PMID: 26396053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2013
First Posted
May 29, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
May 3, 2017
Results First Posted
May 3, 2017
Record last verified: 2017-03