Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
NCT ID: NCT01142726
Last Updated: 2016-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2010-12-31
2014-10-31
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
DOUBLE
Study Groups
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Abatacept, 125 mg, plus methotrexate, 2.5 mg
Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Methotrexate, 2.5 mg, plus abatacept placebo
Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
Abatacept, 125 mg, plus methotrexate placebo
Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
Interventions
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Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
Methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Onset of persistent symptoms ≤ 2 years prior to screening
* Positive test result for anticyclic citrullinated peptides 2
* Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
* Biologic naive, including no treatment with an investigational biologic prior to screening
* Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
* Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
* If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
* Able to undergo magnetic resonance imaging
Exclusion Criteria
* Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
* Scheduled for or anticipating joint replacement surgery
* Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
* History of malignancy in the last 5 years
* Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
* At risk for tuberculosis
* Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment
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
St. Joseph'S Mercy Clinic
Hot Springs, Arkansas, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States
Johns Hopkins University Division Of Rheumatology
Baltimore, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Arthritis Associates Of Mississippi
Jackson, Mississippi, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Piedmont Rheumatology, Pa
Hickory, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Isam A. Diab, Md
Middleburg, Ohio, United States
Alan J. Kivitz, Md, Cpi
Duncansville, Pennsylvania, United States
Mitchell C. Feinman, Md
Orangeburg, South Carolina, United States
Kurt Oelke, Md
Glendale, Wisconsin, United States
Local Institution
Cairns, Queensland, Australia
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Woodville, South Australia, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Malvern, Victoria, Australia
Local Institution
Victoria Park, Western Australia, Australia
Local Institution
Brussels, , Belgium
Local Institution
Kortrijk, , Belgium
Local Institution
Merksem, , Belgium
Local Institution
Calgary, Alberta, Canada
Local Institution
Laval, Quebec, Canada
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Hjørring, , Denmark
Local Institution
Helsinki, , Finland
Local Institution
Tampere, , Finland
Local Institution
Chambray-lès-Tours, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
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Poitiers, , France
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Berlin, , Germany
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Berlin, , Germany
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Hildesheim, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Ancona, , Italy
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Siena, , Italy
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Chihuahua City, Chihuahua, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Metepec, State of Mexico, Mexico
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Mérida, Yucatán, Mexico
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Querétaro, , Mexico
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Lublin, , Poland
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Poznan, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroc#aw, , Poland
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Moscow, , Russia
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Moscow, , Russia
Local Institution
Tver', , Russia
Local Institution
Kempton Park, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Pretoria, 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
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Gothenburg, , Sweden
Local Institution
Linköping, , Sweden
Local Institution
Malmo, , Sweden
Local Institution
Stockholm, , Sweden
Local Institution
Uppsala, , Sweden
Countries
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References
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Ahmad HA, Baker JF, Conaghan PG, Emery P, Huizinga TWJ, Elbez Y, Banerjee S, Ostergaard M. Prediction of flare following remission and treatment withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb trial with abatacept. Arthritis Res Ther. 2022 Feb 16;24(1):47. doi: 10.1186/s13075-022-02735-8.
Keystone EC, Ahmad HA, Yazici Y, Bergman MJ. Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials. Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455.
Ahmad HA, Baker JF, Ostergaard M, Ye J, Emery P, Conaghan PG. Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial. Adv Ther. 2019 Sep;36(9):2384-2393. doi: 10.1007/s12325-019-01020-6. Epub 2019 Jul 5.
Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Maldonado MA, Huizinga TW. Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study. RMD Open. 2019 Feb 8;5(1):e000840. doi: 10.1136/rmdopen-2018-000840. eCollection 2019.
Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P. On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis. Rheumatol Int. 2018 Dec;38(12):2225-2231. doi: 10.1007/s00296-018-4173-3. Epub 2018 Oct 20.
Peterfy C, Burmester GR, Bykerk VP, Combe BG, DiCarlo JC, Furst DE, Huizinga TW, Wong DA, Conaghan PG, Emery P. Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis. Ann Rheum Dis. 2016 Aug;75(8):1501-5. doi: 10.1136/annrheumdis-2015-208258. Epub 2016 Feb 10.
Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Barre E, Karyekar CS, Wong DA, Huizinga TW. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015 Jan;74(1):19-26. doi: 10.1136/annrheumdis-2014-206106. Epub 2014 Nov 3.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-018674-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-226
Identifier Type: -
Identifier Source: org_study_id
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