Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
- Registration Number
- NCT01864148
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIIB033, 100 mg/kg Avonex BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. BIIB033, 3 mg/kg BIIB033 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, 3 mg/kg Avonex 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 BIIB033 BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. BIIB033, 10 mg/kg Avonex 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 BIIB033 BIIB033 30 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 Avonex 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 BIIB033 BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. Placebo Placebo Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. Placebo Avonex Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
- Primary Outcome Measures
Name Time Method Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint 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
Name Time Method Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint 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.
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs 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.
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84 Up to 84 weeks
Trial Locations
- Locations (68)
OMRF Multiple Sclerosis Center of Excellence
🇺🇸Oklahoma City, Oklahoma, United States
Research Site
🇨🇦Montreal, Quebec, Canada
Stanford University Medical Center
🇺🇸Stanford, California, United States
Multiple Sclerosis Center of North Eastern New York
🇺🇸Latham, New York, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Raleigh Neurology Associates PA
🇺🇸Raleigh, California, United States
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Pécsi Tudományegyetem
🇭🇺Pécs, Hungary
Hôpital Roger Salengro
🇫🇷Lille, Nord, France
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
🇵🇱Rybnik, Poland
Hospital General Carlos Haya
🇪🇸Malaga, Spain
London Health Sciences Centre
🇨🇦London, Canada
Perm State Medical Academy
🇷🇺Perm, Russian Federation
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czech Republic
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
🇵🇱Katowice, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
🇵🇱Poznan, Poland
Republican Clinical Hospital For Rehabilitation Treatment
🇷🇺Kazan, Russian Federation
EUROMEDIS Sp. z o.o.
🇵🇱Szczecin, Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
🇵🇱Plewiska, Poland
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
🇭🇺Budapest, Hungary
Kaluga Regional Hospital
🇷🇺Kaluga, Russian Federation
Zuyderland Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Nemocnice Jihlava Prispevkova Organizace
🇨🇿Jihlava, Vysocina, Czech Republic
NEUROSPOL Sro
🇨🇿Havirov, Czech Republic
Fondazione Istituto San Raffaele G. Giglio di Cefalù
🇮🇹Cefalù, Palermo, Italy
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Krajska Zdravotni a.s. Nemocnice Teplice Oz
🇨🇿Teplice, Ústecký kraj, Czech Republic
Hôpital Guillaume Et René Laënnec
🇫🇷Nantes, Loire-Atlantique, France
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Military Medical Academy
🇷🇸Belgrade, Serbia
Azienda Ospedaliera S. Antonio Abate di Gallarate
🇮🇹Gallarate, Varese, Italy
Fondation Rothschild
🇫🇷Paris, France
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
🇷🇺Saint-Petersburg, Russian Federation
Krasnoyarsk State Medical Academy
🇷🇺Krasnoyarsk, Russian Federation
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Michigan Institute For Neurological Disorders
🇺🇸Farmington Hills, Michigan, United States
Immunoe International Research Center
🇺🇸Centennial, Colorado, United States
Phoenix Neurological Associates
🇺🇸Phoenix, Arizona, United States
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, Hlavní Mesto, Czech Republic
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Králové, Královéhradecký kraj, Czech Republic
Hôpital Maison Blanche
🇫🇷Reims, Marne, France
Hôpital Sud
🇫🇷Amiens, Somme, France
Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
CHRU Nancy
🇫🇷Nancy, France
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Liguria, Italy
General Hospital Uzice
🇷🇸Uzice, Serbia
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
🇮🇹Montichiari, Lombardia, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Centrum Neurologii K. Selmaj
🇵🇱Lódz, Lódzkie, Poland
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
🇵🇱Gdansk, Poland
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Mazowieckie, Poland
Novo-Med Zielinski i wsp. Sp.J.
🇵🇱Katowice, Slaskie, Poland
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
🇵🇱Katowice, Poland
Regional Clinical Hospital #3
🇷🇺Volgograd, Russian Federation
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Hospital Universitari de Bellvitge
🇪🇸l Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Córdoba, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Madrid, Communidad Delaware, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Queen's Medical Centre
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Hospital de Basurto Osakidetza
🇪🇸Bilbao, Vizcaya, Spain
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
🇵🇱Grudziądz, Poland
North Central Neurology Assoc PC
🇺🇸Cullman, Alabama, United States