Clinical trial NCT01064401: Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Official title: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2010-02-08
Enrollment: 1841
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.


Eligibility criteria: Key Inclusion Criteria:

* Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
* Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
* Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Key Exclusion Criteria:

* Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
* History of treatment with Daclizumab High Yield Process (Dac HYP)
* History of malignancy
* History of severe allergic or anaphylactic reactions
* Known hypersensitivity to study drugs or their excipients
* History of abnormal laboratory results indicative of any significant disease
* History of human immunodeficiency virus (HIV) or other immunodeficient conditions
* History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
* History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
* History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
* An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
* Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
* Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
* Exposure to varicella zoster virus within 21 days before screening

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Adjusted Annualized Relapse Rate (ARR)
timeFrame: Up to 144 weeks
Secondary outcomes:
measure: Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
timeFrame: up to 96 weeks
measure: Proportion of Participants With Sustained Disability Progression at 144 Weeks
timeFrame: Baseline through 144 weeks
measure: Proportion of Participants Relapse-free at Week 144
timeFrame: 144 weeks
measure: Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks
timeFrame: Baseline and 96 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: La Jolla
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Naples
country: United States
facility: Research Site
state: Florida
city: Pompano Beach
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Worchester
country: United States
facility: Research Site
state: Massachusetts
city: Clinton Township
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Lebanon
country: United States
facility: Research Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Latham
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston Salem
country: United States
facility: Research Site
state: North Carolina
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburg
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Godoy Cruz
country: Argentina
facility: Research Site
state: Mendoza
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Research Site
state: New South Wales
city: Auchenflower
country: Australia
facility: Research Site
state: Queensland
city: Woodville
country: Australia
facility: Research Site
state: South Australia
city: Fitzroy
country: Australia
facility: Research Site
state: Victoria
city: Heidelberg West
country: Australia
facility: Research Site
state: Victoria
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Bahia
city: Brasilia
country: Brazil
facility: Research Site
state: Distrito Federal
city: Recife
country: Brazil
facility: Research Site
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande
city: Sao Paulo
country: Brazil
facility: Research Site
state: Rio Grande
city: Campinas
country: Brazil
facility: Research Site
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Research Site
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Saint John
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Regina
country: Canada
facility: Research Site
state: Saskatchewan
city: Brno
country: Czech Republic
facility: Research Site
state: Jihocesky Kraj
city: Jihlava
country: Czech Republic
facility: Research Site
state: Kraj Vysocina
city: Olomouc
country: Czech Republic
facility: Research Site
state: Olomoucký kraj
city: Praha 10
country: Czech Republic
facility: Research Site
state: Praha
city: Praha 2
country: Czech Republic
facility: Research Site
state: Praha
city: Havirov
country: Czech Republic
facility: Research Site
state: Severomoravksy Krav
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Copenhagen
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Århus
country: Denmark
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
state: Western Finalnd
city: Helsinki
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Seinäjoki
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
state: Alsace
city: Caen Cedex 5
country: France
facility: Research Site
state: Basse-normandie
city: Bobigny
country: France
facility: Research Site
state: Ile-de-france
city: Paris Cedex 5
country: France
facility: Research Site
state: Ile-de-france
city: Paris
country: France
facility: Research Site
state: Ile-de-france
city: Amiens
country: France
facility: Research Site
state: Picardie
city: Nice
country: France
facility: Research Site
state: Provence Alpes Cote D'azur
city: Lyon
country: France
facility: Research Site
state: Rhone-alpes
city: Bourdeaux
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lomme
country: France
facility: Research Site
city: Marseille Cedex 9
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Toulouse Cedex 3
country: France
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
state: Baden-wuerttemberg
city: Bad Mergentheim
country: Germany
facility: Research Site
state: Baden-Wurttemberg
city: Bamberg
country: Germany
facility: Research Site
state: Bayern
city: Bayreuth
country: Germany
facility: Research Site
state: Bayern
city: München
country: Germany
facility: Research Site
state: Bayern
city: Neuburg an der Donau
country: Germany
facility: Research Site
state: Bayern
city: Marburg
country: Germany
facility: Research Site
state: Hessen
city: Essen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Koln
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Munster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
state: Attica
city: Heraklion
country: Greece
facility: Research Site
state: Crete
city: Thessaloniki
country: Greece
facility: Research Site
state: Macedoni
city: Székesfehérvár
country: Hungary
facility: Research Site
state: Fejer
city: Gyor
country: Hungary
facility: Research Site
state: Gyor-moson-sopron
city: Budapest
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Veszprém
country: Hungary
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Delhi
country: India
facility: Research Site
state: Dwivdee
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: New Delhi
country: India
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
state: Ashqelon
city: Tzrifin
country: Israel
facility: Research Site
state: Beer Yaakov
city: Petach Tikva
country: Israel
facility: Research Site
state: Petah Tiqwa
city: Beer-Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Tzfat
country: Israel
facility: Research Site
city: Cefalù
country: Italy
facility: Research Site
state: PA
city: Orbassano
country: Italy
facility: Research Site
state: Torino
city: Bari
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Chisinau
country: Moldova, Republic of
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Grudziadz
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Lódz
country: Poland
facility: Research Site
state: Lodzkie
city: Kraków
country: Poland
facility: Research Site
state: Malopolskie
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Bialystok
country: Poland
facility: Research Site
state: Podlaskie
city: Gdansk
country: Poland
facility: Research Site
state: Pomorskie
city: Katowice
country: Poland
facility: Research Site
state: Slaskie
city: Kielce
country: Poland
facility: Research Site
state: Swietokrzycie
city: Olsztyn
country: Poland
facility: Research Site
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Research Site
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Research Site
state: Zachodniopomorskie
city: Bydgoszczas
country: Poland
facility: Research Site
city: Plewiska
country: Poland
facility: Research Site
city: Bucurest
country: Romania
facility: Research Site
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Research Site
state: Cluj
city: Timisoara
country: Romania
facility: Research Site
state: Timis
city: Iasi
country: Romania
facility: Research Site
city: Târgu Mures
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
state: Povolje-Tatarstan
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Ural
city: Yaroslavl
country: Russian Federation
facility: Research Site
state: Yaroslavlr
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: L´Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Dnepropetrovsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Vinnitsa
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: New Castle Upon Tyne
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Salford
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Cohan S, Kappos L, Giovannoni G, Wiendl H, Selmaj K, Havrdova EK, Rose J, Greenberg S, Phillips G, Ma W, Wang P, Lima G, Sabatella G. Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Mult Scler. 2018 Dec;24(14):1883-1891. doi: 10.1177/1352458517735190. Epub 2017 Oct 6.
citation: Benedict RH, Cohan S, Lynch SG, Riester K, Wang P, Castro-Borrero W, Elkins J, Sabatella G. Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study. Mult Scler. 2018 May;24(6):795-804. doi: 10.1177/1352458517707345. Epub 2017 May 9.
citation: Liu Y, Vollmer T, Havrdova E, Riester K, Lee A, Phillips G, Wang P, Sabatella G. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017 Jan;11:18-24. doi: 10.1016/j.msard.2016.11.005. Epub 2016 Nov 13.
citation: Krueger JG, Kircik L, Hougeir F, Friedman A, You X, Lucas N, Greenberg SJ, Sweetser M, Castro-Borrero W, McCroskery P, Elkins J. Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis. Adv Ther. 2016 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 1.
citation: Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.