Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2492 participants
INTERVENTIONAL
2008-01-31
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Methotrexate-Inadequate Response Autoinjector Device Sub Study
NCT01844895
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
NCT01960855
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT04909801
A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
NCT02141997
Methotrexate - Inadequate Response Device Sub-Study
NCT01173120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subcutaneous (SC) Abatacept
Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Subcutaneous (SC) Abatacept
Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Intravenous (IV) Abatacept
Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
Intravenous (IV) Abatacept
Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
500mg (for body weight up to 60 kg)
750 mg (body weight between 61 and 100 kg)
1g (body weight above 100 kg)infusions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Subcutaneous (SC) Abatacept
Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Intravenous (IV) Abatacept
Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
500mg (for body weight up to 60 kg)
750 mg (body weight between 61 and 100 kg)
1g (body weight above 100 kg)infusions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
Exclusion Criteria
* Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
* Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Subjects with severe chronic or recurrent bacterial infections
* Subjects who have received treatment with rituximab
An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rheumatology Associates, Pc
Birmingham, Alabama, United States
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Advanced Arthritis Care & Research
Scottsdale, Arizona, United States
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States
St. Joseph'S Mercy Clinic
Hot Springs, Arkansas, United States
Talbert Medical Group
Huntington Beach, California, United States
Allergy & Rheumatology Medical Clinic, Inc.
La Jolla, California, United States
Valerius Medical Group &Research Ctr. Of Greater Long Beach
Long Beach, California, United States
Stanford University School Of Medicine
Palo Alto, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Arthritis Center Of The Rockies, Pc
Loveland, Colorado, United States
Guadagnoli, Germano
Bridgeport, Connecticut, United States
Joao Nascimento
Bridgeport, Connecticut, United States
Clinical Research Center Of Ct/Ny
Danbury, Connecticut, United States
Arthritis And Rheumatic Disease Specialties
Aventura, Florida, United States
Arthritis & Osteoporosis Treatment Center, Pa
Orange Park, Florida, United States
Rheumatology Associates Of Central Florida
Orlando, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Arthritis & Rheumatology Of Georgia,Pc
Atlanta, Georgia, United States
Boise Rheumatology/ Intermountain Research Center, Inc
Boise, Idaho, United States
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States
Quincy Medical Group
Quincy, Illinois, United States
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, United States
The Arthritis Center
Springfield, Illinois, United States
Klein And Associates, M.D., Pa
Cumberland, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Shores Rheumatology, P. C.
Saint Clair Shores, Michigan, United States
Arthritis Assoicates Of Mississippi
Jackson, Mississippi, United States
Kansas City Internal Medicine
Lee's Summit, Missouri, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Allergy And Arthritis Associates
Dover, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Albuquerque Rehabilitation & Rheumatology Pc
Albuquerque, New Mexico, United States
The Center For Rheumatology, Llp
Albany, New York, United States
Southern Tier Arthritis & Rheumatism
Olean, New York, United States
Arthritis Health Associates
Syracuse, New York, United States
Asheville Rheumatology & Osteoporosis Research Asso P. A.
Asheville, North Carolina, United States
The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina, United States
Rheumatology
Durham, North Carolina, United States
Physicians East, Pa
Greenville, North Carolina, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
Oklahoma Center For Arthritis Therapy And Research
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Pro Research
Eugene, Oregon, United States
Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Rheumatology Associates
Providence, Rhode Island, United States
Low Country Rheumatology, Pa
Charleston, South Carolina, United States
Columbia Arthritis Center
Columbia, South Carolina, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
Acme Research, Llc
Orangeburg, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States
The Arthritis Group, Pc
Memphis, Tennessee, United States
St. Thomas Hospital Tower East
Nashville, Tennessee, United States
Walter F. Chase
Austin, Texas, United States
Rheumatic Disease Clinical Research Center, Llc
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Texas Research Center
Sugarland, Texas, United States
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States
Center For Arthritis & Rheumatic Diseases, Pc
Chesapeake, Virginia, United States
South Puget Sound Clinincal Research Center
Olympia, Washington, United States
Tacoma Center For Arthritis Research Ps
Tacoma, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad Autonoma, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Rosario, Santa Fe, Santa Fe Province, Argentina
Local Institution
Santa Fe, Santa Fe Province, Argentina
Local Institution
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution
St Leonards, New South Wales, Australia
Local Institution
Cairns, Queensland, Australia
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Woodville, South Australia, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Shenton Park, Western Australia, Australia
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Hasselt, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
Wilrijk, , Belgium
Local Institution
Yvoir, , Belgium
Local Institution
Goiânia, Goiás, Brazil
Local Institution
Goiânia, Goiás, Brazil
Local Institution
Juiz de Fora, Minas Gerais, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Recife, Pernambuco, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
St. John's, Newfoundland and Labrador, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Mississauga, Ontario, Canada
Local Institution
Ottawa, Ontario, Canada
Local Institution
Ste-Foy, Quebec, Canada
Local Institution
Ste-Foy, Quebec, Canada
Local Institution
Trois-Rivières, Quebec, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Bordeaux, , France
Local Institution
Brest, , France
Local Institution
Chambray-lès-Tours, , France
Local Institution
Le Mans, , France
Local Institution
Lille, , France
Local Institution
Marseille, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Poitiers, , France
Local Institution
Strasbourg, , France
Local Institution
Berlin, , Germany
Local Institution
Leipzig, , Germany
Local Institution
München, , Germany
Local Institution
München, , Germany
Local Institution
Heraklion Crete, , Greece
Local Institution
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Secunderabad, Andhra Pradesh, India
Local Institution
Navrangpura, Ahmedabad, Gujarat, India
Local Institution
Bangalore, Karnataka, India
Local Institution
Bangalore, , India
Local Institution
Hyderabad, , India
Local Institution
Lucknow, , India
Local Institution
New Delhi, , India
Local Institution
Dublin, Dublin, Ireland
Local Institution
Napoli, , Italy
Local Institution
Padua, , Italy
Local Institution
Pavia, , Italy
Local Institution
Roma, , Italy
Local Institution
Siena, , Italy
Local Institution
Aguascalientes, Aguascalientes, Mexico
Local Institution
Chihuahua City, Chihuahua, Mexico
Local Institution
Tijuana, Estado de Baja California, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Morelia, Michioacan, Mexico
Local Institution
Nuevo León, Nuevo León, Mexico
Local Institution
Querétaro City, Querétaro, Mexico
Local Institution
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Leeuwarden, , Netherlands
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Callao, Provincia Constitucional del Callao, Peru
Local Institution
Bialystok, , Poland
Local Institution
Bialystok, , Poland
Local Institution
Bydgoszcz, , Poland
Local Institution
Gmina Końskie, , Poland
Local Institution
Krakow, , Poland
Local Institution
Poznan, , Poland
Local Institution
Poznan, , Poland
Local Institution
Torun, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Yaroslavl, , Russia
Local Institution
Yekaterinburg, , Russia
Local Institution
Kempton Park, Gauteng, South Africa
Local Institution
Muckleneuk, Gauteng, South Africa
Local Institution
Muckleneuk, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Durban, KwaZulu-Natal, South Africa
Local Institution
Panorama, Western Cape, South Africa
Local Institution
Seoul, Sungdong-Gu, South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Denizli, , Turkey (Türkiye)
Local Institution
Edirne, , Turkey (Türkiye)
Local Institution
Gaziantep, , Turkey (Türkiye)
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Local Institution
Bridgend, Glamorgan, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Southampton, Hampshire, United Kingdom
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.
Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.
Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT # 2007-005434-37
Identifier Type: -
Identifier Source: secondary_id
IM101-174
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.