Effects of Abatacept in Patients With Early Rheumatoid Arthritis
NCT ID: NCT02504268
Last Updated: 2021-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
994 participants
INTERVENTIONAL
2015-09-03
2020-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Combination Therapy: Abatacept + Methotrexate
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Abatacept
Methotrexate
Methotrexate treatment
Methotrexate at least 15mg per week tablet or capsule orally
Methotrexate
Abatacept Placebo
Placebo for Abatacept subcutaneous injection once per week
Abatacept Placebo
Methotrexate Placebo
Placebo to match Methotrexate capsule orally once per week
Methotrexate Placebo
Interventions
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Abatacept
Methotrexate
Abatacept Placebo
Methotrexate Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States
Arizona Arthritis & Rheumatology Research PLLC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Sun City, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States
St. Joseph Heritage Medical Group
Fullerton, California, United States
Healthcare Partners Medical Group
Huntington Beach, California, United States
Valerius Medical Group and Research Center
Los Alamitos, California, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States
Joao Nascimento
Bridgeport, Connecticut, United States
Rheumatology Associates Of Central Florida, P.A.
Orlando, Florida, United States
Tampa Medical Group, Pa
Tampa, Florida, United States
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States
Arthritis And Diabetes Clinic
Monroe, Louisiana, United States
Klein And Associates, M.D., Pa
Hagerstown, Maryland, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Arthritis Consultants
St Louis, Missouri, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Arthritis And Osteoporosis Associates, Pa
Freehold, New Jersey, United States
Physicians Research Center, Llc
Toms River, New Jersey, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Hospital For Special Surgery
New York, New York, United States
Local Institution
Hickory, North Carolina, United States
Pmg Research Of Salisbury
Salisbury, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
Oklahoma Ctr For Arthritis Therapy And Research, Inc.
Tulsa, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center Of Reading, Llp
Wyomissing, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Houston Institute For Clinical Research
Houston, Texas, United States
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Arthritis Northwest
Spokane, Washington, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Organizacion Medica De Investigacion S.A. (Omi)
Capital Federal, Buenos Aires, Argentina
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Hospital General De Agudos J.M. Ramos Mejia
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Framingham Centro Medico
La Plata, Buenos Aires, Argentina
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, Argentina
Caici
Rosario, Santa Fe Province, Argentina
Instituto De Rehabilitacion Psicofisica
Buenos Aires, , Argentina
Centro Consultora Integral de Salud SRL
Córdoba, , Argentina
Hospital Privado-Centro Medico De Cordoba S.A.
Córdoba, , Argentina
Centro De Investigaciones Reumatologicas
San Miguel de Tucumán, , Argentina
Centro Medico Privado De Reumatologia
San Miguel de Tucumán, , Argentina
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Southport, Queensland, Australia
Local Institution
Hobart, Tasmania, Australia
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Camberwell, Victoria, Australia
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Coffs Harbour, , Australia
Rheuma Zentrum Favoriten
Vienna, , Austria
Local Institution
Juiz de Fora, Minas Gerais, Brazil
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Varginha, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Winnipeg, Manitoba, Canada
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Montreal, Quebec, Canada
Centre De Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Local Institution
Saskatchewan, Saskatchewan, Canada
Centro Medico de Reumatologia Limitada
Temuco, Región de la Araucanía, Chile
Centro De Estudios Reumatologicos
Santiago, Santiago Metropolitan, Chile
Someal
Santiago, Santiago Metropolitan, Chile
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
Bogotá, , Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogotá, , Colombia
Clinica de Artritis Temprana
Cali, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Oddeleni klinicke farmakologie
Plzen-Bory, , Czechia
Revmatologicky ustav
Prague, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
PV Medical Services, s.r.o.
Zlín, , Czechia
Local Institution
Hyvinkää, , Finland
Local Institution
Kuopio, , Finland
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Lyon, , France
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Orléans, , France
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Poitiers, , France
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Toulouse, , France
Rheumapraxis Dr. Kurthen
Aachen, , Germany
Charite Campus Mitte
Berlin, , Germany
Rheumatologische Schwerpunktpraxis Dr. Zinke
Berlin, , Germany
Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
Berlin, , Germany
Schlosspark-Klinik
Berlin, , Germany
Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
Burghausen, , Germany
Klinikum Der Albrecht-Ludwigs-Universitat
Freiburg im Breisgau, , Germany
MVZ Rheuma
Hamburg, , Germany
Hamburger Rheuma Forschungszentrum
Hamburg, , Germany
Gemeinschaftspraxis Drs. von Hinueber u Demary
Hildesheim, , Germany
Rheumatologie In Wuermtal
Planegg, , Germany
Praxis Dr. Walter
Rendsburg, , Germany
Local Institution
Budapest, , Hungary
Belgyogy. Int. Reuma. DEOEC
Debrecen, , Hungary
Vaszary Kolos Hospital
Esztergom, , Hungary
Reumatologiai Osztaly Flor F.
Kistarcsa, , Hungary
Reumatologiai Osztaly MAV
Szolnok, , Hungary
Vital Medical Center
Veszprém, , Hungary
Local Institution
Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Litwinsky, , Israel
Local Institution
Zrifin, , Israel
Ospedale Vittorio Emanuele
Catania, , Italy
Istituto Gaetano Pini
Milan, , Italy
Azienda Ospedaliera Luigi Sacco
Milan, , Italy
Local Institution
Pavia, , Italy
Local Institution
Roma, , Italy
Ospedale Borgo Roma
Verona, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Hiroshima, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kato-shi, Hyōgo, Japan
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Hitachi-Naka, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Kagoshima, Kagoshima-ken, Japan
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Sagamihara-shi, Kanagawa, Japan
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Isahaya-shi, Nagasaki, Japan
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Sasebo-shi, Nagasaki, Japan
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Tomigusuku-shi, Okinawa, Japan
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Izumisano, Osaka, Japan
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Kawachi-Nagano, Osaka, Japan
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Iruma-gun, Saitama, Japan
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Kawagoe-shi, Saitama, Japan
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Sayama-shi, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Chuo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Shinjuku-Ku, Tokyo, Japan
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Mexico City, Distrito Fededral, Mexico
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Mexicali, Estado de Baja California, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, , Mexico
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México D.F., , Mexico
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San Luis Potosí City, , Mexico
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Monaco, , Monaco
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Leiden, , Netherlands
Local Institution
Lima, , Peru
Acq Medic Sac
Lima, , Peru
Clinica El Golf
Lima, , Peru
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, , Peru
Nszoz Unica Cr
Dąbrówka, , Poland
Nzoz Mak Med
Nadarzyn, , Poland
SANUS Szpital Specjalistyczny Sp. z o.o.
Stalowa Wola, , Poland
Local Institution
Staszów, , Poland
Slaski Szpital Reumatologiczno - Rehabilitacyjny
Ustroń, , Poland
Instytut Reumatologii, I Klinika Reumatologii
Warsaw, , Poland
Centrum Medyczne AMED Sp. z o.o.
Warsaw, , Poland
Local Institution
Doha, , Qatar
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Port Elizabeth, Eastern Cape, South Africa
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Soweto, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Pinelands, Cape Town, Western Cape, South Africa
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Stellenbosch, Western Cape, South Africa
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Anyang-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santiago Compostela, , Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Leeds, North Yorkshire, United Kingdom
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Hull, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Emery P, Fleischmann R, Wong R, Lozenski K, Tanaka Y, Bykerk V, Bingham CO 3rd, Huizinga TWJ, Citera G, Perera V, Murthy B, Maxwell KF, Passarell J, Hedrich WD, Williams D. Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study. J Rheumatol. 2025 May 1;52(5):426-435. doi: 10.3899/jrheum.2024-0498.
Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TWJ, Citera G, Huang KG, Wu C, Connolly SE, Elbez Y, Wong R, Lozenski K, Fleischmann R. The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study. Arthritis Res Ther. 2023 Apr 22;25(1):67. doi: 10.1186/s13075-023-03038-2.
Emery P, Tanaka Y, Bykerk VP, Huizinga TWJ, Citera G, Bingham CO 3rd, Banerjee S, Soule BP, Nys M, Connolly SE, Lozenski KL, Zhuo J, Wong R, Huang KG, Fleischmann R. Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis. Rheumatol Ther. 2023 Jun;10(3):707-727. doi: 10.1007/s40744-022-00519-9. Epub 2023 Mar 3.
Wu C, Hu Y, Schafer P, Connolly SE, Wong R, Nielsen SH, Bay-Jensen AC, Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TW, Fleischmann R, Liu J. Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis. RMD Open. 2022 Dec;8(2):e002683. doi: 10.1136/rmdopen-2022-002683.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2015-001275-50
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-550
Identifier Type: -
Identifier Source: org_study_id
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