Clinical trial NCT01864148: Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
timeFrame: 72 weeks
Secondary outcomes:
measure: Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
timeFrame: 72 weeks
measure: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
timeFrame: Up to 84 weeks
measure: Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
timeFrame: Up to 84 weeks
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Assoc PC
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Neurological Associates
state: Arizona
city: Raleigh
country: United States
facility: Raleigh Neurology Associates PA
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Centennial
country: United States
facility: Immunoe International Research Center
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Institute For Neurological Disorders
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Latham
country: United States
facility: Multiple Sclerosis Center of North Eastern New York
state: New York
city: Oklahoma City
country: United States
facility: OMRF Multiple Sclerosis Center of Excellence
state: Oklahoma
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Ottowa
country: Canada
facility: Research Site
state: Ontario
city: Gatinueau
country: Canada
facility: Research Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: London
country: Canada
facility: London Health Sciences Centre
city: Praha
country: Czech Republic
facility: Vseobecna Fakultni Nemocnice V Praze
state: Hlavní Mesto
city: Hradec Králové
country: Czech Republic
facility: Fakultni Nemocnice Hradec Kralove
state: Královéhradecký kraj
city: Jihlava
country: Czech Republic
facility: Nemocnice Jihlava Prispevkova Organizace
state: Vysocina
city: Havirov
country: Czech Republic
facility: NEUROSPOL Sro
city: Praha 5
country: Czech Republic
facility: Fakultni nemocnice v Motole
city: Teplice
country: Czech Republic
facility: Krajska Zdravotni a.s. Nemocnice Teplice Oz
state: Ústecký kraj
city: Nantes
country: France
facility: Hôpital Guillaume Et René Laënnec
state: Loire-Atlantique
city: Reims
country: France
facility: Hôpital Maison Blanche
state: Marne
city: Lille
country: France
facility: Hôpital Roger Salengro
state: Nord
city: Amiens
country: France
facility: Hôpital Sud
state: Somme
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Nancy
country: France
facility: CHRU Nancy
city: Paris
country: France
facility: Fondation Rothschild
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
state: Lombardia
city: Montichiari
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
state: Lombardia
city: Cefalù
country: Italy
facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù
state: Palermo
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
state: Sicilia
city: Gallarate
country: Italy
facility: Azienda Ospedaliera S. Antonio Abate di Gallarate
state: Varese
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Lódz
country: Poland
facility: Centrum Neurologii K. Selmaj
state: Lódzkie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Katowice
country: Poland
facility: Novo-Med Zielinski i wsp. Sp.J.
state: Slaskie
city: Gdansk
country: Poland
facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
city: Grudziądz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
city: Katowice
country: Poland
facility: M.A.- Lek A.M.Maciejowscy Spolka Cywilna
city: Katowice
country: Poland
facility: Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z o.o.
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Hospital
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital For Rehabilitation Treatment
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical Academy
city: Perm
country: Russian Federation
facility: Perm State Medical Academy
city: Saint-Petersburg
country: Russian Federation
facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
city: Volgograd
country: Russian Federation
facility: Regional Clinical Hospital #3
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Uzice
country: Serbia
facility: General Hospital Uzice
city: l Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
state: Cataluña
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Córdoba
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Madrid, Communidad Delaware
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Basurto Osakidetza
state: Vizcaya
city: Malaga
country: Spain
facility: Hospital General Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: Nottinghamshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Wilhelm 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.