Clinical trial NCT02504268: Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Official title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Detailed description: Subcutaneous (SC)

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Rheumatoid arthritis (RA) diagnosis less than 6 months
* CRP \> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
* At least 3 swollen and 3 tender joints
* Anti-citrullinated protein antibodies (ACPA) positive

Exclusion Criteria:

* At risk for tuberculosis
* Have acute infection
* Have chronic or recurrent bacterial or serious latent viral infection
* History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
* Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)

Primary outcomes:
measure: Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants in SDAI Remission at Week 52
timeFrame: Week 52
measure: Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
timeFrame: Week 52
measure: Percentage of Participants in Boolean Remission at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Sun City
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Hot Springs
country: United States
facility: CHI St. Vincent Medical Group Hot Springs
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic
state: Arkansas
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Huntington Beach
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group and Research Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Bridgeport
country: United States
facility: Joao Nascimento
state: Connecticut
city: Orlando
country: United States
facility: Rheumatology Associates Of Central Florida, P.A.
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, Pa
state: Florida
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthrit Clin
state: Idaho
city: Monroe
country: United States
facility: Arthritis And Diabetes Clinic
state: Louisiana
city: Hagerstown
country: United States
facility: Klein And Associates, M.D., Pa
state: Maryland
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Freehold
country: United States
facility: Arthritis And Osteoporosis Associates, Pa
state: New Jersey
city: Toms River
country: United States
facility: Physicians Research Center, Llc
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: New York
country: United States
facility: Hospital For Special Surgery
state: New York
city: Hickory
country: United States
facility: Local Institution
state: North Carolina
city: Salisbury
country: United States
facility: Pmg Research Of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Wilmington
country: United States
facility: Pmg Research Of Wilmington Llc
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Ctr For Arthritis Therapy And Research, Inc.
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center Of Reading, Llp
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Houston Institute For Clinical Research
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic Of Northern Virginia, P.C.
state: Virginia
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Organizacion Medica De Investigacion S.A. (Omi)
state: Buenos Aires
city: Ciudad Autonoma Beunos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Hospital General De Agudos J.M. Ramos Mejia
state: Buenos Aires
city: La Plata
country: Argentina
facility: Framingham Centro Medico
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Instituto de Asistencia Reumatologica Integral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Caici
state: Santa FE
city: Buenos Aires
country: Argentina
facility: Instituto De Rehabilitacion Psicofisica
city: Cordoba
country: Argentina
facility: Centro Consultora Integral de Salud SRL
city: Cordoba
country: Argentina
facility: Hospital Privado-Centro Medico De Cordoba S.A.
city: Tucuman
country: Argentina
facility: Centro De Investigaciones Reumatologicas
city: Tucuman
country: Argentina
facility: Centro Medico Privado De Reumatologia
city: Maroochydore
country: Australia
facility: Local Institution
state: Queensland
city: Southport
country: Australia
facility: Local Institution
state: Queensland
city: Hobart
country: Australia
facility: Local Institution
state: Tasmania
city: Camberwell
country: Australia
facility: Local Institution
state: Victoria
city: Coffs Harbour
country: Australia
facility: Local Institution
city: Wien
country: Austria
facility: Rheuma Zentrum Favoriten
city: Juiz De Fora
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Varginha
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Santo Andre
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Saskatchewan
country: Canada
facility: Local Institution
city: Temuco
country: Chile
facility: Centro Medico de Reumatologia Limitada
state: Araucania
city: Santiago De Chile
country: Chile
facility: Centro De Estudios Reumatologicos
state: Metropolitana
city: Santiago
country: Chile
facility: Someal
state: Metropolitana
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
city: Cali
country: Colombia
facility: Clinica de Artritis Temprana
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Plzen-Bory
country: Czechia
facility: Oddeleni klinicke farmakologie
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Zlin
country: Czechia
facility: PV Medical Services, s.r.o.
city: Hyvinkaa
country: Finland
facility: Local Institution
city: Kuopio
country: Finland
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Orleans cedex 2
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Toulouse cedex 9
country: France
facility: Local Institution
city: Aachen
country: Germany
facility: Rheumapraxis Dr. Kurthen
city: Berlin
country: Germany
facility: Charite Campus Mitte
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis Dr. Zinke
city: Berlin
country: Germany
facility: Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Burghausen
country: Germany
facility: Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
city: Freiburg
country: Germany
facility: Klinikum Der Albrecht-Ludwigs-Universitat
city: Hamburg
country: Germany
facility: MVZ Rheuma
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Drs. von Hinueber u Demary
city: Planegg
country: Germany
facility: Rheumatologie In Wuermtal
city: Rendsburg
country: Germany
facility: Praxis Dr. Walter
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Belgyogy. Int. Reuma. DEOEC
city: Esztergom
country: Hungary
facility: Vaszary Kolos Hospital
city: Kistarcsa
country: Hungary
facility: Reumatologiai Osztaly Flor F.
city: Szolnok
country: Hungary
facility: Reumatologiai Osztaly MAV
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Haifa
country: Israel
facility: Local Institution
city: Petach Tikva
country: Israel
facility: Local Institution
city: Ramat-gan
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Zrifin
country: Israel
facility: Local Institution
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele
city: Milano
country: Italy
facility: Istituto Gaetano Pini
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Pavia
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Verona
country: Italy
facility: Ospedale Borgo Roma
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Hiroshima-Shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kato-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Hitachinaka-shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Mito-shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Sagamihara-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Isahaya-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Tomigusuku-shi
country: Japan
facility: Local Institution
state: Okinawa
city: Izumisano-shi
country: Japan
facility: Local Institution
state: Osaka
city: Kawachinagano
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-gun
country: Japan
facility: Local Institution
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Local Institution
state: Saitama
city: Sayama-shi
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Anyang-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Mexicali
country: Mexico
facility: Local Institution
state: Baja California
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Fededral
city: León
country: Mexico
facility: Local Institution
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
city: México D.F.
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Monaco
country: Monaco
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Acq Medic Sac
city: Lima
country: Peru
facility: Clinica El Golf
city: Lima
country: Peru
facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
city: Dabrowka
country: Poland
facility: Nszoz Unica Cr
city: Nadarzyn
country: Poland
facility: Nzoz Mak Med
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny Sp. z o.o.
city: Staszow
country: Poland
facility: Local Institution
city: Ustron
country: Poland
facility: Slaski Szpital Reumatologiczno - Rehabilitacyjny
city: Warszawa
country: Poland
facility: Instytut Reumatologii, I Klinika Reumatologii
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Sp. z o.o.
city: Doha
country: Qatar
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj-napoca
country: Romania
facility: Local Institution
city: Ekaterinburg
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Pinelands, Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Local Institution
state: Western Cape
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Santiago Compostela
country: Spain
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
city: Leeds
country: United Kingdom
facility: Local Institution
state: North Yorkshire
city: Hull
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: