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The medical conditions and diseases this study investigates.

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NCT02504268

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
NCT01142726
CompletedInterventionalPhase 3Updated Jan 14, 2016
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
NCT00122382
CompletedInterventionalPhase 3Updated Nov 16, 2010
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
NCT00048568
CompletedInterventionalPhase 3Updated Dec 5, 2011
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
NCT02557100
CompletedInterventionalPhase 4Updated Sep 3, 2020
Abatacept With Methotrexate- Phase IIB
NCT00162266
CompletedInterventionalPhase 2Updated Jun 1, 2012
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT00409838
CompletedInterventionalPhase 3Updated Aug 8, 2013

Effects of Abatacept in Patients With Early Rheumatoid Arthritis | NCT02504268 | Trialant

CompletedInterventionalPhase 3Updated Jun 28, 2021

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

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

ClinicalTrials.gov ID: NCT02504268
Lead Sponsor: Bristol-Myers SquibbINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 3
Enrollment: 994Actual
Last Update Posted: Jun 28, 2021Actual
Start Date: Sep 3, 2015Actual
Primary Completion Date: Jan 16, 2017Actual
Completion Date: Mar 19, 2020Actual

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
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)

Rheumatoid Arthritis

Abatacept
Methotrexate
Abatacept Placebo
Methotrexate Placebo

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

No central contacts

There are no central contacts for this study.

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama 35801, United States

Arizona Arthritis & Rheumatology Research PLLC

Glendale, Arizona 85306, United States

Arizona Arthritis & Rheumatology Research PLLC

Mesa, Arizona 85210, United States

Arizona Arthritis & Rheumatology Research PLLC

Phoenix, Arizona 85032, United States

Arizona Arthritis & Rheumatology Research PLLC

Phoenix, Arizona 85037, United States

Arizona Arthritis & Rheumatology Research PLLC

Sun City, Arizona 85351, United States

CHI St. Vincent Medical Group Hot Springs

Hot Springs, Arkansas 71913, United States

Arkansas Primary Care Clinic

Little Rock, Arkansas 72204, United States

St. Joseph Heritage Medical Group

Fullerton, California 92835, United States

Healthcare Partners Medical Group

Huntington Beach, California 92646, United States

Valerius Medical Group and Research Center

Los Alamitos, California 90720, United States

Inland Rheumatology Clinical Trials Inc.

Upland, California 91786, United States

Joao Nascimento

Bridgeport, Connecticut 06606, United States

Rheumatology Associates Of Central Florida, P.A.

Orlando, Florida 32806, United States

Tampa Medical Group, Pa

Tampa, Florida 33614, United States

Coeur D'Alene Arthrit Clin

Coeur d'Alene, Idaho 83814, United States

Arthritis And Diabetes Clinic

Monroe, Louisiana 71203, United States

Klein And Associates, M.D., Pa

Hagerstown, Maryland 21740, United States

St. Paul Rheumatology, P.A.

Eagan, Minnesota 55121, United States

Arthritis Consultants

St Louis, Missouri 63141, United States

Physician Research Collaboration, Llc

Lincoln, Nebraska 68516, United States

Arthritis And Osteoporosis Associates, Pa

Freehold, New Jersey 07728, United States

Physicians Research Center, Llc

Toms River, New Jersey 08755, United States

Albuquerque Center For Rheumatology

Albuquerque, New Mexico 87102, United States

Albuquerque Clinical Trials

Albuquerque, New Mexico 87102, United States

Hospital For Special Surgery

New York, New York 10021-4892, United States

Local Institution

Hickory, North Carolina 28601, United States

Pmg Research Of Salisbury

Salisbury, North Carolina 28144, United States

Carolina Arthritis Associates

Wilmington, North Carolina 28401, United States

Pmg Research Of Wilmington Llc

Wilmington, North Carolina 28401, United States

Health Research Of Oklahoma

Oklahoma City, Oklahoma 73103, United States

Oklahoma Ctr For Arthritis Therapy And Research, Inc.

Tulsa, Oklahoma 74104, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania 16635, United States

The Arthritis Group

Philadelphia, Pennsylvania 19152, United States

Clinical Research Center Of Reading, Llp

Wyomissing, Pennsylvania 19610, United States

West Tennessee Research Institute

Jackson, Tennessee 38305, United States

Metroplex Clinical Research Center

Dallas, Texas 75231, United States

Houston Institute For Clinical Research

Houston, Texas 77074, United States

Arthritis Clinic Of Northern Virginia, P.C.

Arlington, Virginia 22205, United States

Spectrum Medical, Inc.

Danville, Virginia 24541, United States

Arthritis Northwest

Spokane, Washington 99204, United States

Rheumatic Disease Center

Glendale, Wisconsin 53217, United States

Organizacion Medica De Investigacion S.A. (Omi)

Capital Federal, Buenos Aires 1015, Argentina

Local Institution

Ciudad Autonoma Beunos Aires, Buenos Aires 1431, Argentina

Hospital General De Agudos J.M. Ramos Mejia

Ciudad Autonoma de Buenos Aire, Buenos Aires 1221, Argentina

Framingham Centro Medico

La Plata, Buenos Aires 1902, Argentina

Instituto de Asistencia Reumatologica Integral

San Fernando, Buenos Aires 1646, Argentina

Caici

Rosario, Santa Fe Province 2000, Argentina

Instituto De Rehabilitacion Psicofisica

Buenos Aires, 1428, Argentina

Centro Consultora Integral de Salud SRL

Córdoba, 5004, Argentina

Hospital Privado-Centro Medico De Cordoba S.A.

Córdoba, 5016, Argentina

Centro De Investigaciones Reumatologicas

San Miguel de Tucumán, 4000, Argentina

Centro Medico Privado De Reumatologia

San Miguel de Tucumán, 4000, Argentina

Local Institution

Maroochydore, Queensland 4558, Australia

Local Institution

Southport, Queensland 4215, Australia

Local Institution

Hobart, Tasmania 7000, Australia

Local Institution

Camberwell, Victoria 3124, Australia

Local Institution

Coffs Harbour, 2450, Australia

Rheuma Zentrum Favoriten

Vienna, 1100, Austria

Local Institution

Juiz de Fora, Minas Gerais 36010-570, Brazil

Local Institution

Varginha, Minas Gerais 37006-710, Brazil

Local Institution

Curitiba, Paraná 80030-110, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul 90480-000, Brazil

Local Institution

Santo André, São Paulo 09060-870, Brazil

Local Institution

São Paulo, 01228-200, Brazil

Local Institution

São Paulo, 04032-060, Brazil

Local Institution

São Paulo, 04266-010, Brazil

Local Institution

Winnipeg, Manitoba R3A 1M3, Canada

Local Institution

Montreal, Quebec H2L 1S6, Canada

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec G8Z 1Y2, Canada

Local Institution

Saskatchewan, Saskatchewan S7K 0H6, Canada

Centro Medico de Reumatologia Limitada

Temuco, Araucania 4790928, Chile

Centro De Estudios Reumatologicos

Santiago, Santiago Metropolitan 7501126, Chile

Someal

Santiago, Santiago Metropolitan 7510586, 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, MEDELLIN, Colombia

Oddeleni klinicke farmakologie

Plzen-Bory, 305 99, Czechia

Revmatologicky ustav

Prague, 128 50, Czechia

MEDICAL PLUS, s.r.o.

Uherské Hradiště, 686 01, Czechia

PV Medical Services, s.r.o.

Zlín, 760 01, Czechia

Local Institution

Hyvinkää, 05800, Finland

Local Institution

Kuopio, 70110, Finland

Local Institution

Lyon, 69437, France

Local Institution

Orléans, 45067, France

Local Institution

Poitiers, 86021, France

Local Institution

Toulouse, 31059, France

Rheumapraxis Dr. Kurthen

Aachen, 52064, Germany

Charite Campus Mitte

Berlin, 10117, Germany

Rheumatologische Schwerpunktpraxis Dr. Zinke

Berlin, 13055, Germany

Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch

Berlin, 13125, Germany

Schlosspark-Klinik

Berlin, 14059, Germany

Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken

Burghausen, 84489, Germany

Klinikum Der Albrecht-Ludwigs-Universitat

Freiburg im Breisgau, 79106, Germany

MVZ Rheuma

Hamburg, 20095, Germany

Hamburger Rheuma Forschungszentrum

Hamburg, 22391, Germany

Gemeinschaftspraxis Drs. von Hinueber u Demary

Hildesheim, 31134, Germany

Rheumatologie In Wuermtal

Planegg, 82152, Germany

Praxis Dr. Walter

Rendsburg, 24768, Germany

Local Institution

Budapest, 1027, Hungary

Belgyogy. Int. Reuma. DEOEC

Debrecen, 4032, Hungary

Vaszary Kolos Hospital

Esztergom, 2500, Hungary

Reumatologiai Osztaly Flor F.

Kistarcsa, 2143, Hungary

Reumatologiai Osztaly MAV

Szolnok, 5000, Hungary

Vital Medical Center

Veszprém, 8200, Hungary

Local Institution

Haifa, 31096, Israel

Local Institution

Petah Tikva, 4941492, Israel

Local Institution

Ramat Gan, 52621, Israel

Local Institution

Tel Litwinsky, 52620, Israel

Local Institution

Zrifin, Israel

Ospedale Vittorio Emanuele

Catania, 95123, Italy

Istituto Gaetano Pini

Milan, 20122, Italy

Azienda Ospedaliera Luigi Sacco

Milan, 20154, Italy

Local Institution

Pavia, 27100, Italy

Local Institution

Roma, 00168, Italy

Ospedale Borgo Roma

Verona, 37134, Italy

Local Institution

Nagoya, Aichi-ken 4578511, Japan

Local Institution

Nagoya, Aichi-ken 4668560, Japan

Local Institution

Fukuoka, Fukuoka 8108563, Japan

Local Institution

Kitakyushu-shi, Fukuoka 8078556, Japan

Local Institution

Hiroshima, Hiroshima 7348551, Japan

Local Institution

Sapporo, Hokkaido 0608604, Japan

Local Institution

Sapporo, Hokkaido 0608648, Japan

Local Institution

Sapporo, Hokkaido 0630811, Japan

Local Institution

Kato-shi, Hyōgo 6731462, Japan

Local Institution

Hitachi-Naka, Ibaraki 3120057, Japan

Local Institution

Mito, Ibaraki 3100015, Japan

Local Institution

Kagoshima, Kagoshima-ken 8900063, Japan

Local Institution

Sagamihara-shi, Kanagawa 2520392, Japan

Local Institution

Isahaya-shi, Nagasaki 8548501, Japan

Local Institution

Sasebo-shi, Nagasaki 8571195, Japan

Local Institution

Tomigusuku-shi, Okinawa 9010224, Japan

Local Institution

Izumisano, Osaka 5988577, Japan

Local Institution

Kawachi-Nagano, Osaka 5868521, Japan

Local Institution

Iruma-gun, Saitama 3500495, Japan

Local Institution

Kawagoe-shi, Saitama 3508550, Japan

Local Institution

Sayama-shi, Saitama 3501305, Japan

Local Institution

Hamamatsu, Shizuoka 4308558, Japan

Local Institution

Chuo-ku, Tokyo 1048560, Japan

Local Institution

Itabashi-ku, Tokyo 1738610, Japan

Local Institution

Meguro-ku, Tokyo 1528902, Japan

Local Institution

Meguro-ku, Tokyo 1538515, Japan

Local Institution

Shinjuku-Ku, Tokyo 1608582, Japan

Local Institution

Mexico City, Distrito Fededral 11850, Mexico

Local Institution

Mexicali, Estado de Baja California, Mexico

Local Institution

León, Guanajuato 37000, Mexico

Local Institution

Guadalajara, Jalisco 44280, Mexico

Local Institution

Guadalajara, Jalisco 44600, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Mexico

Local Institution

México D.F., Mexico

Local Institution

San Luis Potosí City, 78213, Mexico

Local Institution

Monaco, 98012, Monaco

Local Institution

Leiden, 2333 ZA, Netherlands

Local Institution

Lima, 27, Peru

Acq Medic Sac

Lima, LIMA 11, Peru

Clinica El Golf

Lima, Lima 27, Peru

Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, LIMA 33, Peru

Nszoz Unica Cr

Dąbrówka, 62-069, Poland

Nzoz Mak Med

Nadarzyn, 05-830, Poland

SANUS Szpital Specjalistyczny Sp. z o.o.

Stalowa Wola, 37-450, Poland

Local Institution

Staszów, 28-200, Poland

Slaski Szpital Reumatologiczno - Rehabilitacyjny

Ustroń, 43-450, Poland

Instytut Reumatologii, I Klinika Reumatologii

Warsaw, 02637, Poland

Centrum Medyczne AMED Sp. z o.o.

Warsaw, 03-291, Poland

Local Institution

Doha, Qatar

Local Institution

Bucharest, 011192, Romania

Local Institution

Bucharest, 020983, Romania

Local Institution

Cluj-Napoca, 400006, Romania

Local Institution

Moscow, 119049, Russia

Local Institution

Saint Petersburg, 191124, Russia

Local Institution

Saint Petersburg, 197022, Russia

Local Institution

Yaroslavl, 150003, Russia

Local Institution

Yekaterinburg, 620102, Russia

Local Institution

Singapore, 117549, Singapore

Local Institution

Singapore, 169856, Singapore

Local Institution

Port Elizabeth, Eastern Cape 6045, South Africa

Local Institution

Soweto, Gauteng 2013, South Africa

Local Institution

Cape Town, Western Cape 7500, South Africa

Local Institution

Pinelands, Cape Town, Western Cape 7405, South Africa

Local Institution

Stellenbosch, Western Cape 7600, South Africa

Local Institution

Anyang-si, Gyeonggi-do 14068, South Korea

Local Institution

Seongnam-si, Gyeonggi-do 13620, South Korea

Local Institution

Seoul, 04763, South Korea

Local Institution

A Coruña, 15006, Spain

Local Institution

Barcelona, 08036, Spain

Local Institution

Madrid, 28006, Spain

Local Institution

Madrid, 28046, Spain

Local Institution

Santiago Compostela, 15702, Spain

Local Institution

Gothenburg, 413 45, Sweden

Local Institution

Malmö, 205 02, Sweden

Local Institution

Stockholm, 171 76, Sweden

Local Institution

Uppsala, 751 85, Sweden

Local Institution

Tainan, 704, Taiwan

Local Institution

Taipei, 100, Taiwan

Local Institution

Taipei, 112, Taiwan

Local Institution

Taoyuan, 333, Taiwan

Local Institution

Leeds, North Yorkshire LS7 4SA, United Kingdom

Local Institution

Hull, HU3 2JZ, United Kingdom

Local Institution

Manchester, M13 9WL, United Kingdom

Lead Sponsor: Bristol-Myers SquibbINDUSTRY