Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01864148
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: BIIB033 Other: Placebo Drug: Avonex Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIIB033, 3 mg/kg

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.

Drug: BIIB033
Other Name: anti-LINGO-1 mAb

Drug: Avonex
Other Name: interferon beta-1a

Experimental: BIIB033, 10 mg/kg

BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Drug: BIIB033
Other Name: anti-LINGO-1 mAb

Drug: Avonex
Other Name: interferon beta-1a

Experimental: BIIB033, 30 mg/kg

BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Drug: BIIB033
Other Name: anti-LINGO-1 mAb

Drug: Avonex
Other Name: interferon beta-1a

Experimental: BIIB033, 100 mg/kg

BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Drug: BIIB033
Other Name: anti-LINGO-1 mAb

Drug: Avonex
Other Name: interferon beta-1a

Placebo Comparator: Placebo

Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.

Other: Placebo
Drug: Avonex
Other Name: interferon beta-1a




Primary Outcome Measures :
  1. Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint [ Time Frame: 72 weeks ]
    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 :
  1. Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint [ Time Frame: 72 weeks ]
    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.

  2. Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs [ Time Frame: Up to 84 weeks ]
    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.

  3. Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84 [ Time Frame: Up to 84 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864148


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
North Central Neurology Assoc PC
Cullman, Alabama, United States, 35058
United States, Arizona
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
United States, California
Raleigh Neurology Associates PA
Raleigh, California, United States, 27607-6000
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
Immunoe International Research Center
Centennial, Colorado, United States, 80112
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Multiple Sclerosis Center of North Eastern New York
Latham, New York, United States, 12110
United States, Oklahoma
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, United States, 73104
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Canada, Ontario
Research Site
Ottowa, Ontario, Canada
Canada, Quebec
Research Site
Gatinueau, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Levis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Canada
London Health Sciences Centre
London, Canada, N6A 5A5
Czech Republic
Vseobecna Fakultni Nemocnice V Praze
Praha, Hlavní Mesto, Czech Republic, 128 08
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Královéhradecký kraj, Czech Republic, 500 05
Nemocnice Jihlava Prispevkova Organizace
Jihlava, Vysocina, Czech Republic, 586 33
NEUROSPOL Sro
Havirov, Czech Republic, 736 01
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
Krajska Zdravotni a.s. Nemocnice Teplice Oz
Teplice, Ústecký kraj, Czech Republic, 415 29
France
Hôpital Guillaume Et René Laënnec
Nantes, Loire-Atlantique, France, 44805
Hôpital Maison Blanche
Reims, Marne, France, 51092
Hôpital Roger Salengro
Lille, Nord, France, 59000
Hôpital Sud
Amiens, Somme, France, 80054
Hopital Gabriel Montpied
Clermont-Ferrand, France, 63003
CHRU Nancy
Nancy, France, 54000
Fondation Rothschild
Paris, France, 75019
Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád, Hungary, 6725
Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
Budapest, Hungary, 1204
Pécsi Tudományegyetem
Pécs, Hungary, 7623
Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Liguria, Italy, 16132
Ospedale San Raffaele S.r.l.
Milano, Lombardia, Italy, 20127
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
Montichiari, Lombardia, Italy, 25018
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, Italy, 90015
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
Catania, Sicilia, Italy, 95123
Azienda Ospedaliera S. Antonio Abate di Gallarate
Gallarate, Varese, Italy, 21013
Netherlands
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Zuyderland Medisch Centrum
Sittard-Geleen, Netherlands, 6162 BG
Poland
Centrum Neurologii K. Selmaj
Lódz, Lódzkie, Poland, 93-121
Wojskowy Instytut Medyczny
Warszawa, Mazowieckie, Poland, 00-901
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Slaskie, Poland, 40-650
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, Poland, 80-803
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziądz, Poland, 86-300
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
Katowice, Poland, 40-595
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
Katowice, Poland, 40-749
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
Plewiska, Poland, 62-064
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, Poland, 61-853
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
Rybnik, Poland, 44-200
EUROMEDIS Sp. z o.o.
Szczecin, Poland, 70-215
Russian Federation
Kaluga Regional Hospital
Kaluga, Russian Federation, 248007
Republican Clinical Hospital For Rehabilitation Treatment
Kazan, Russian Federation, 420021
Krasnoyarsk State Medical Academy
Krasnoyarsk, Russian Federation, 660049
Perm State Medical Academy
Perm, Russian Federation, 614990
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Saint-Petersburg, Russian Federation, 197110
Regional Clinical Hospital #3
Volgograd, Russian Federation, 400001
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
General Hospital Uzice
Uzice, Serbia, 31000
Spain
Hospital Universitari de Bellvitge
l Hospitalet de Llobregat, Barcelona, Spain, 8907
Hospital Universitario Vall d'Hebron
Barcelona, Cataluña, Spain, 8035
Hospital Universitario Reina Sofia
Cordoba, Córdoba, Spain, 14008
Hospital Clinico San Carlos
Madrid, Madrid, Communidad Delaware, Spain, 28040
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital de Basurto Osakidetza
Bilbao, Vizcaya, Spain, 48013
Hospital General Carlos Haya
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41071
United Kingdom
Queen's Medical Centre
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01864148     History of Changes
Other Study ID Numbers: 215MS201
2011-006262-40 ( EudraCT Number )
First Posted: May 29, 2013    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic