Drugs / Abatacept
Abatacept
also known as
Orencia · BMS-188667 · CTLA4Ig · ABA · Abatacept Injection · CTLA4-IgG4m · Dr. Reddy's Abatacept · KSHB002 · +1 more
Other / unclassified targets CD28, CD80, CD86 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute graft versus host disease 1 milestone | |||||
| Filed | US (FDA) | Orencia | acute graft versus host disease | 2021-08-23 | “the FDA has accepted its supplemental sBLA for Orencia ® (abatacept) for the prevention of moderate to severe acute graft versus host disease” bms.com ↗ “FDA has accepted its supplemental Biologics License Application (sBLA) for Orencia” bms.com ↗ |
| Filed rheumatoid arthritis 3 milestones | |||||
| Filed | US (FDA) | ORENCIA | rheumatoid arthritis | 2010-10-04 | “Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.” bms.com ↗ |
| Filed | US (FDA) | ORENCIA | rheumatoid arthritis | 2009-01-27 | “accepted for filing by the FDA for the use of ORENCIA for patients with early rheumatoid arthritis” bms.com ↗ |
| Filed | EU (EMA) | ORENCIA | rheumatoid arthritis | — | “In August, the European Medicines Agency (EMA) validated for review the application for ORENCIA SC.” bms.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (10) | US (FDA) | ORENCIA | — | 2007-03-13 – 2023-10-30 | fda.gov ↗ |
| Approved | EU (EMA) | Orencia | — | 2007-05-21 | europa.eu ↗ |
| Approved | US (FDA) | ORENCIA | — | 2005-12-23 | fda.gov ↗ |
Trials 142 · started per year
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EU approved 2007
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 06 trials | ||||||
| Phase 0 | NCT06731504 | Nov 2025 → Dec 2027 expected | hematopoietic and lymphoid cell neoplasm | Duke University | Recruiting | No outcome recorded |
| Phase 0 | NCT04344873 | Sep 2025 → Nov 2026 | cardiovascular disorder | University of Utah | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT04118153 | Mar 2021 → May 2024 | type 1 diabetes mellitus | Sandra Lord, MD | Completed | No outcome recorded |
| Phase 0 | NCT04946669 | Feb 2021 → Jul 2022 | dermatomyositis | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT03059888 | Apr 2017 → Jul 2019 | myasthenia gravis | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 0 | NCT01693640 | Jun 2012 → Dec 2018 | Behcet disease | NYU Langone Health | Completed | No outcome recorded |
| Phase 121 trials | ||||||
| Phase 1 | NCT07388563 | Mar 2026 → Mar 2027 expected | adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma +1 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06008808 | May 2024 → Sep 2027 expected | graft versus host disease | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06126042 | Oct 2023 → Apr 2024 | rheumatoid arthritis | Dr. Reddy's Laboratories Limited | Unknown | No outcome recorded |
| Phase 1 | NCT05981976 | Aug → Dec 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05975450 | Aug 2023 → Feb 2025 | — | Idelberto Badell | Completed | No outcome recorded |
| Phase 1 | NCT06307301 | Oct 2021 → Dec 2022 | amyotrophic lateral sclerosis | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT04203875 | Mar → Jul 2020 | autoimmune hepatitis | Stuart Knechtle, M.D. | Terminated | No outcome recorded |
| Phase 1 | NCT03714022 | Nov 2018 → Apr 2019 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02805010 | Oct 2016 → Feb 2017 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02867800 | Jul 2016 → Dec 2021 | graft versus host disease, sickle cell disease | Monica Bhatia | Completed | No outcome recorded |
| Phase 1 | NCT02281058 | Jan 2015 → Nov 2017 | vitiligo | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT01917708 | Jan 2014 → Sep 2019 | Chediak-Higashi syndrome, Diamond-Blackfan anemia, Fanconi anemia, Glanzmann thrombasthenia +9 | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01890473 | Jul 2013 → Nov 2014 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01439204 | Oct 2011 → Feb 2012 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01272856 | Jan 2011 → May 2012 | relapsing polychondritis | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01221636 | Oct 2010 → Feb 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 1 | NCT00705367 | Aug 2008 → Jan 2009 | lupus nephritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00162201 | Oct 2003 → Apr 2005 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00277199 | Sep → Dec 2002 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00277225 | Nov 1995 → Jun 1996 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00306878 | Aug 1995 → May 1997 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/216 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07599176 | Jul 2026 → Jun 2032 expected | beta thalassemia, sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06681922 | Sep 2024 → Oct 2027 expected | graft versus host disease | Northwell Health | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03733067 | Nov 2023 | autoimmune lymphoproliferative syndrome due to CTLA4 haploinsufficiency | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05426252 | Mar 2022 → Dec 2025 overdue | thalassemia | The Hospital for Sick Children | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05289167 | Mar 2022 → Aug 2026 overdue | graft versus host disease | Northwell Health | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04686929 | Jun 2021 → May 2023 | acute graft versus host disease | The First Affiliated Hospital of Soochow University | Completed | No outcome recorded |
| Phase 1/2 | NCT04503616 | Sep 2020 → Dec 2022 | graft versus host disease | NYU Langone Health | Completed | No outcome recorded |
| Phase 1/2 | NCT04477642 | Aug → Oct 2020 | COVID-19 | Beth Israel Deaconess Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03128996 | Mar 2017 → Apr 2028 expected | bone marrow failure syndrome, metabolic disease, sickle cell disease | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01954979 | Mar 2014 → Jun 2023 | chronic graft versus host disease | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00886795 | May 2009 → Mar 2013 | chronic urticaria | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1/2 | NCT00442611 | Nov 2008 → Jun 2011 | diffuse cutaneous systemic sclerosis | Stanford University | Completed | Met primary |
| Phase 1/2 | NCT00468208 | Feb 2008 → Aug 2011 | granulomatosis with polyangiitis | University of Pennsylvania | Completed | No outcome recorded |
| Phase 1/2 | NCT00094380 | Sep 2004 → Jan 2006 | lupus nephritis, systemic lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00920972 | Dec 2001 → Dec 2026 expected | inherited hemoglobinopathy, metabolic disease | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT00279760 | ? → Mar 2002 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 241 trials · 3 met primary · 8 missed | ||||||
| Phase 2 | NCT06680661 | Apr 2026 → Oct 2027 | Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +2 | Leland Metheny | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06859424 | Jul 2025 → Jun 2028 expected | B-cell chronic lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia +3 | Center for International Blood and Marrow Transplant Research | Recruiting | No outcome recorded |
| Phase 2 | NCT07238712 | May 2025 → Dec 2026 expected | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myeloid leukemia, myelodysplastic syndrome | St. Petersburg State Pavlov Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT05917522 | Dec 2023 → Jul 2027 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT05195645 | Oct 2022 → Mar 2024 | myocarditis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT05621759 | Sep 2022 → Jan 2027 expected | graft versus host disease | NYU Langone Health | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04380740 | Mar 2022 → May 2027 expected | graft versus host disease | Boston Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04872218 | Mar 2022 → May 2024 | food allergy | Philippe Bégin | Completed | No outcome recorded |
| Phase 2 | NCT04955366 | Sep 2021 → Jun 2026 | disease related to solid organ transplantation | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT04925375 | Jul 2021 → Jul 2026 overdue | common variable immunodeficiency, interstitial lung disease | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
| Phase 2 | NCT04472494 | Oct 2020 → Aug 2021 | COVID-19 | Bristol-Myers Squibb | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT04261023 | Feb 2020 → Mar 2021 | arthritic joint disease | University of Leeds | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04186871 | Jan 2020 → Dec 2022 | Sjogren syndrome, rheumatoid arthritis, systemic lupus erythematosus | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT03680092 | Nov 2019 → Jun 2023 | graft versus host disease, hematopoietic and lymphoid cell neoplasm | Dimitrios Tzachanis, MD PhD | Completed | Met primary |
| Phase 2 | NCT04120831 | Oct 2019 → Sep 2020 | rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 2 | NCT03924401 | Aug 2019 → Mar 2027 expected | graft versus host disease | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03871361 | Apr 2019 → Jan 2022 | uveitis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT03669861 | Nov 2018 → Apr 2020 | immunoglobulin G4-related sclerosing disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03457142 | Sep 2018 → Nov 2022 | plasma cell myeloma | Roswell Park Cancer Institute | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03084419 | Jun 2018 → Mar 2020 | interstitial lung disease, rheumatoid arthritis | Cambridge University Hospitals NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 2 | NCT03215927 | Jan 2018 → May 2022 | interstitial lung disease, myositis disease | Rohit Aggarwal, MD | Completed | Missed primary |
| Phase 2 | NCT02592798 | Mar 2016 → Jan 2020 | focal segmental glomerulosclerosis, minimal change disease, nephrotic syndrome | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT01999868 | Mar 2014 → Dec 2017 | psoriasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02027298 | Nov 2013 → Oct 2014 | Sjogren syndrome, rheumatoid arthritis | The Cleveland Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02018042 | Sep 2013 → Jul 2017 | alopecia areata | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT01743131 | Feb 2013 → Jun 2018 | acute graft versus host disease, cancer | Boston Children's Hospital | Completed | Met primary |
| Phase 2 | NCT01279954 | Jan 2012 → Jun 2017 | uveitis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT01315938 | Jan 2011 → Nov 2013 | dermatomyositis | Karolinska Institutet | Completed | No outcome recorded |
| Phase 2 | NCT01116427 | Sep 2010 → Jun 2014 | relapsing-remitting multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT01012492 | Nov 2009 → Nov 2012 | acute biphenotypic leukemia, acute undifferentiated leukemia, myelodysplastic syndrome associated with isolated del(5q), myelodysplastic syndrome with excess blasts-1 +3 | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00556439 | Dec 2008 → Aug 2015 | Takayasu arteritis, temporal arteritis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | Mixed |
| Phase 2 | NCT00774852 | Nov 2008 → Dec 2012 | lupus nephritis, systemic lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT00784459 | Oct 2008 → Dec 2011 | allergic asthma | Washington University School of Medicine | Completed | Missed primary |
| Phase 2 | NCT00739960 | Aug → Dec 2008 | sarcoidosis | University of Chicago | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00558506 | Jan 2008 → Oct 2009 | ankylosing spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT00276250 | Dec 2005 → Dec 2014 | type 1 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00119678 | Sep 2005 → Nov 2008 | systemic lupus erythematosus | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT00162266 | Oct 2000 → Sep 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 2 | NCT00162279 | Oct 2000 → Feb 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00287547 | Mar 1997 → Jan 1998 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT06475820 | Dec 2023 → Jul 2024 overdue | acute biphenotypic leukemia, myelodysplastic syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01333878 | Mar 2011 → Nov 2013 | rheumatoid arthritis | Orrin T Troum, M.D. and Medical Associates | Completed | No outcome recorded |
| Phase 2/3 | NCT00430677 | Jun 2007 → Sep 2010 | systemic lupus erythematosus | Bristol-Myers Squibb | Terminated | Missed primary |
| Phase 334 trials · 3 met primary · 8 missed | ||||||
| Phase 3 | NCT05428488 | Nov 2022 → Nov 2026 expected | rheumatoid arthritis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT05451615 | Sep 2022 → Jun 2023 | rheumatoid arthritis | Zhejiang Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05515029 | Aug 2022 → Aug 2024 overdue | acute biphenotypic leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05335928 | Jul 2022 → Nov 2026 expected | acute myocarditis, cancer | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04909801 | Sep 2021 → Jun 2023 overdue | rheumatoid arthritis | Bristol-Myers Squibb | Active not recruiting | Missed primary |
| Phase 3 | NCT04474847 | Mar 2021 → Dec 2029 expected | arteritis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT03841357 | Oct 2019 → Jan 2025 | oligoarticular juvenile idiopathic arthritis | Duke University | Completed | Missed primary |
| Phase 3 | NCT03632187 | Dec 2018 → Oct 2021 | polymyalgia rheumatica | University Hospital, Brest | Completed | Missed primary |
| Phase 3 | NCT03192969 | Jul 2017 → Jun 2020 | temporal arteritis | Bristol-Myers Squibb | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02840175 | May 2017 → Oct 2019 | juvenile idiopathic arthritis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT02915159 | Dec 2016 → Aug 2018 | Sjogren syndrome | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 3 | NCT02722694 | Aug 2016 → Jun 2017 | rheumatoid arthritis | Jiangsu Simcere Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02504268 | Sep 2015 → Jan 2017 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 3 | NCT02108860 | Apr 2015 → Jul 2023 | granulomatosis with polyangiitis | University of South Florida | Completed | No outcome recorded |
| Phase 3 | NCT01844518 | Aug 2013 → Mar 2015 | polyarticular juvenile idiopathic arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01835470 | Aug 2013 → Nov 2015 | juvenile idiopathic arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01860976 | Jun 2013 → Jul 2015 | psoriatic arthritis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT01844895 | Apr 2013 → Jul 2014 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01714817 | Jan 2013 → Nov 2016 | lupus nephritis | Bristol-Myers Squibb | Terminated | Missed primary |
| Phase 3 | NCT01351480 | Jun 2011 → Jan 2014 | rheumatoid arthritis | Arthritis & Rheumatic Disease Specialties Research | Completed | No outcome recorded |
| Phase 3 | NCT01299961 | Mar 2011 → Feb 2013 | rheumatoid arthritis | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT02779114 | Jan 2009 → Dec 2017 | rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT00767325 | Dec 2008 → Oct 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00663702 | May 2008 → Dec 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00547521 | Dec 2007 → Dec 2008 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00533897 | Nov 2007 → Dec 2008 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00409838 | Apr 2007 → Jul 2008 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00484289 | Dec 2006 → Dec 2010 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00410410 | Dec 2006 → Jun 2009 | ulcerative colitis | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 3 | NCT00406653 | Dec 2006 → Nov 2009 | Crohn disease | Bristol-Myers Squibb | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT00124982 | Apr 2005 → Aug 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00095173 | Dec 2003 → Jun 2006 | polyarticular juvenile rheumatoid arthritis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00048568 | Dec 2002 → Oct 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 421 trials · 1 met primary | ||||||
| Phase 4 | NCT05822583 | Jul 2023 → Jun 2025 | COVID-19 | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT05303272 | Feb 2021 → Sep 2022 | pemphigus vulgaris | Tongji Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04255134 | Sep 2020 → Oct 2022 | rheumatoid arthritis | St George's, University of London | Completed | No outcome recorded |
| Phase 4 | NCT03669367 | Jun 2019 → Jun 2022 | palindromic rheumatism | Fundacion Clinic per a la Recerca Biomédica | Completed | Met primary |
| Phase 4 | NCT03652961 | Jun 2019 → Sep 2021 | rheumatoid arthritis | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT03882008 | May 2019 → Jun 2023 | rheumatoid arthritis | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT04106804 | Jun 2018 → Aug 2021 | — | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 4 | NCT03492658 | May 2018 → Oct 2021 | rheumatoid arthritis | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03227419 | Jan 2018 → Sep 2024 | rheumatoid arthritis | Lille Catholic University | Unknown | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02652273 | Jan 2016 → Jan 2019 | rheumatoid arthritis | NHS Greater Glasgow and Clyde | Unknown | No outcome recorded |
| Phase 4 | NCT02557100 | Nov 2015 → Mar 2019 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT02594735 | Nov 2015 → Jul 2021 | dermatomyositis | George Washington University | Completed | No outcome recorded |
| Phase 4 | NCT02078882 | Sep 2014 → Oct 2018 | primary biliary cholangitis | Christopher Bowlus, MD | Completed | No outcome recorded |
| Phase 4 | NCT01846975 | May 2013 → Dec 2014 | rheumatoid arthritis | Rüdiger B. Müller | Completed | No outcome recorded |
| Phase 4 | NCT01758198 | Apr 2013 → Dec 2016 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT01717846 | Dec 2012 → Nov 2013 | rheumatoid arthritis | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 4 | NCT01602302 | Jun 2012 → Nov 2020 | rheumatoid arthritis | Medical University of Graz | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01638715 | May 2012 → Aug 2018 | rheumatoid arthritis | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01295151 | Aug 2011 → Nov 2015 | rheumatoid arthritis | Julia Brown | Completed | No outcome recorded |
| Comparator or background therapy54 trials | ||||||
| Phase 1 | NCT06929039 Comparator | Jul → Oct 2024 | rheumatoid arthritis | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT06395038 Comparator | May 2024 → Apr 2026 | frontotemporal dementia | The Methodist Hospital Research Institute | Unknown | No outcome recorded |
| Phase 1 | NCT02923583 Comparator | Oct 2016 → Jul 2017 | — | Momenta Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00279734 Comparator | Aug 2004 → Jan 2005 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT06279494 Background | Mar → Jun 2024 | acute leukemia, aplastic anemia, myelodysplastic syndrome | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT06145282 Background | Dec 2023 → Oct 2025 overdue | sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02429934 Comparator | Oct 2015 → Sep 2019 | systemic lupus erythematosus | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 1/2 | NCT00254293 Comparator | Jan 2006 → May 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT07616154 Background | Sep 2026 → Sep 2034 expected | sickle cell disease | St. Jude Children's Research Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03929601 Comparator | Oct 2023 → Mar 2027 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05742243 Comparator | Feb 2023 → Sep 2025 | type 1 diabetes mellitus | Melbourne Health | Completed | No outcome recorded |
| Phase 2 | NCT03784261 Comparator | Dec 2018 → Dec 2022 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT03411850 Comparator | May 2016 → May 2021 | Sjogren syndrome | Arthritis & Rheumatism Associates, P.C. | Unknown | No outcome recorded |
| Phase 2 | NCT02161406 Comparator | Sep 2014 → Sep 2018 | diffuse cutaneous systemic sclerosis | Dinesh Khanna, MD, MS | Completed | No outcome recorded |
| Phase 2 | NCT02232880 Comparator | Aug 2014 → Jun 2015 | hypertensive disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02270957 Comparator | Jan 2014 → Dec 2018 | systemic lupus erythematosus | Oklahoma Medical Research Foundation | Completed | No outcome recorded |
| Phase 2 | NCT01917058 Comparator | Aug 2013 → Aug 2016 | alopecia areata | Columbia University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01314495 Comparator | Sep 2011 → Jun 2012 | alopecia areata | Julian M. Mackay-Wiggan | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00482066 Comparator | Nov 2007 → Nov 2008 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Imperial College London | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00534313 Comparator | Nov 2007 → Dec 2008 | psoriatic arthritis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT00345748 Comparator | Jun 2006 → Nov 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00124449 Comparator | Feb 2005 → May 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00035529 Comparator | Nov 2001 → Dec 2003 | multiple sclerosis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2/3 | NCT07366801 Comparator | Sep 2025 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting | No outcome recorded |
| Phase 2/3 | NCT01001832 Comparator | Dec 2009 → Feb 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT06654882 Comparator | Jan 2026 → May 2029 expected | polyarticular juvenile idiopathic arthritis | Duke University | Recruiting | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04593940 Comparator | Oct 2020 → Jan 2022 | COVID-19 | Daniel Benjamin | Completed | No outcome recorded |
| Phase 3 | NCT04000698 Background | Oct 2019 → Jul 2022 | acute lymphoblastic leukemia, acute myeloid leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 3 | NCT03086343 Comparator | May 2017 → Jun 2019 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02971683 Comparator | May 2017 → Jul 2020 | dermatomyositis, immune-mediated necrotizing myopathy, juvenile idiopathic inflammatory myopathy, overlap myositis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT02778906 Comparator | Nov 2014 → Dec 2019 | arthritic joint disease | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 3 | NCT02067910 Comparator | Aug 2014 → Feb 2019 | Sjogren syndrome | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT01350804 Comparator | Sep 2011 → Feb 2015 | rheumatoid arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01142726 Comparator | Dec 2010 → Sep 2013 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00929864 Comparator | Oct 2009 → Oct 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00559585 Comparator | Jan 2008 → Nov 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 3 | NCT00420199 Comparator | May 2007 → Aug 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00989235 Comparator | Apr 2007 → Oct 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00122382 Comparator | Jul 2005 → Feb 2008 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00095147 Comparator | Feb 2005 → Jul 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00048581 Comparator | Dec 2002 → Sep 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00048932 Comparator | Dec 2002 → Oct 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT03619876 Comparator | Jul 2019 → Sep 2021 | myocarditis, rheumatoid arthritis | Columbia University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03737708 Background | Feb 2019 → Jun 2020 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02353780 Comparator | Mar 2015 → Dec 2017 | rheumatoid arthritis | Dr. Larry W. Moreland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02466581 Comparator | Feb 2015 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01491815 Comparator | Dec 2012 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01557374 Comparator | Apr 2012 → Nov 2019 | rheumatoid arthritis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT01000441 Comparator | Dec 2009 → Aug 2013 | rheumatoid arthritis | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| — | NCT02547493 Comparator | Mar 2016 → Jan 2021 | rheumatoid arthritis | University Hospital, Montpellier | Completed | No outcome recorded |
| — | NCT02053727 Comparator | Jul 2014 → Jun 2018 | chronic hepatitis B virus infection, rheumatoid arthritis | University of California, Los Angeles | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05170672 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2022-06-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Topline Results Showing Treatment with Orencia (abatacept) Improved Survival in People Hospitalized with COVID-19 bms.com ↗
Analyses of the secondary endpoints, which included mortality and clinical status, demonstrated Orencia reduced participants’ risk of death and improved their clinical status at 28 days after entering the study when compared with placebo. |
| 2021-12-15 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Orencia® (abatacept) in Combination with a Calcineurin Inhibitor and Methotrexate for the Prevention of Acute Graft Versus Host Disease (aGvHD)... bms.com ↗
Orencia is the first and only FDA-approved therapy to help prevent this serious complication that impacts between 30-70% of hematopoietic stem cell transplant recipients |
| 2021-11-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ACR Convergence 2021 Illustrate Scientific Advances for Immune-Mediated Rheumatic Diseases bms.com ↗
Post hoc analysis of the ASCORE study in rheumatoid arthritis (RA) demonstrated that several baseline characteristics were associated with remission in patients with RA treated with subcutaneous Orencia . |
| 2021-08-23 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Orencia (abatacept) for the Prevention of Acute Graft Versus Host Disease (aGvHD) bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT). |
| 2021-06-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at EULAR 2021 Highlight Commitment to Driving Advancements Across Multiple Immune-Mediated Rheumatic Diseases bms.com ↗
Remission rates on Orencia were higher in patients with double positive RA versus double negative RA. |
| 2020-11-05 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ACR Convergence 2020 Underscore Commitment to Advancing Science for Patients with Difficult-to-Treat Immune-Mediated Diseases bms.com ↗
New biomarker data showing that higher baseline levels of fine-specificity ACPAs predict greater treatment response in seropositive RA patients receiving Orencia on background methotrexate therapy versus methotrexate alone. |
| 2020-06-06 | AbbVie | Results AbbVie Presents Data Showing RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA (abatacept) in Rheumatoid Arthritis Patients abbvie.com ↗
In addition, RINVOQ met the key secondary endpoints of superiority versus ORENCIA on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6. |
| 2020-06-03 | Bristol-Myers Squibb | Results New Data Reinforce Improved and Durable Clinical Responses of Orencia in Moderate-to-Severe Early Rheumatoid Arthritis Patients with Autoantibodies Linked to More Severe Disease bms.com ↗
Findings of the open-label switch period showed that early seropositive RA patients treated with Orencia demonstrated substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab. |
| 2020-01-23 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Orencia® (abatacept injection), the innovative drug in the field of rheumatology immunity co-developed by BMS and Simcere, is approved simcere.com ↗
I am very pleased that abatacept has been approved in China, and sincerely congratulate Simcere and BMS. |
| 2019-12-04 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for ORENCIA® (abatacept) to Help Prevent Acute Graft bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA ® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. |
| 2019-11-07 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Underscores Precision-Focused Immunology Leadership with New Data on ORENCIA® (abatacept) in Early RA, ACPA-Positive Patients Presented at 2019 ACR/ARP Annual Meeting1 bms.com ↗
The study showed that, across all ORENCIA treatment arms, patients achieved maintenance of remission and inhibition of structural damage progression at week 48 after de-escalation. |
| 2019-07-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Abatacept in the treatment of severe myocarditis induced by immune checkpoint inhibitors simcere.com ↗
The patient was discharged in 7. 5 weeks after admission. |
| 2019-06-13 | Bristol-Myers Squibb | Results New Mechanistic Study Explores the Relationship Between a Key Genetic Marker and Clinical Efficacy of ORENCIA® (abatacept) or adalimumab in Moderate-to-Severe Early Rheumatoid Arthritis Patients bms.com ↗
ACR 20/50/70 responses with ORENCIA were 83, 70 and 48 respectively; ACR 20/50/70 scores for adalimumab were 63, 45 and 30, respectively. |
| 2018-06-13 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present New Research Findings on the Treatment of Patients with Early Rheumatoid Arthritis at the Annual European Congress of Rheumatology (EULAR 2018) bms.com ↗
Analysis comparing abatacept with adalimumab on measures of sustained remission [DAS28 (CRP) < 2.6] and showing seropositive patients with early, erosive RA may respond differently to targeted biologic therapy. |
| 2017-07-27 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Reports Second Quarter Financial Results bms.com ↗ |
| 2017-07-26 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb’s ORENCIA® (abatacept) Receives Second European Commission Approval in Less than a Year – New Approval for Treatment of Active Psoriatic Arthritis (PsA)1 bms.com ↗
PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which ORENCIA is approved to treat in Europe. |
| 2017-07-06 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb’s ORENCIA (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis (PsA) in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA) 1 , a chronic 2 , inflammatory disease that can affect both the skin and musculoskeletal system. |
| 2017-06-14 | Bristol-Myers Squibb | Results Bristol-Myers Squibb To Present New Research Related to the Treatment of Rheumatoid Arthritis Patients With Highly Active, Progressive Disease at the Annual European Congress of Rheumatology (EULAR 2017) bms.com ↗
A post hoc analysis of the phase 3 AGREE* clinical trial showing that among patients with early, erosive RA, treatment with ORENCIA + MTX (vs. MTX alone) resulted in higher seroconversion rates. |
| 2017-06-08 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Announces Availability of New ORENCIA® (abatacept) Subcutaneous Administration Option for Patients 2 Years of Age and Older with Moderately to Severely Active Polyarticular Juvenile Idiopathic Arthritis (JIA) bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today the availability of a new FDA-approved subcutaneous (SC) ORENCIA administration option for use in patients 2 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA). |
| 2016-11-14 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Showcases Rheumatoid Arthritis and Immunoscience Commitment with Depth of Research at 2016 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting bms.com ↗
Patients with the worst prognostic factors were less likely to have a part-time or full-time job compared with those having a better RA prognosis. |
| 2016-09-06 | Bristol-Myers Squibb | Regulatory European Commission Approves Bristol-Myers Squibb’s ORENCIA® (abatacept) for the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis Not Previously Treated with Methotrexate bms.com ↗
With this approval, ORENCIA is the first biologic therapy with an indication in the European Union (EU) specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease. |
| 2016-07-25 | Bristol-Myers Squibb | Regulatory CHMP Issues Positive Opinion for ORENCIA® (abatacept) in the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis not Previously Treated with Methotrexate in the EU bms.com ↗ |
| 2016-06-08 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Announces New Rheumatoid Arthritis Research and Real-World Data at the Annual European Congress of Rheumatology (EULAR 2016) bms.com ↗
In this study, patients who tested positive via a common blood test for certain biomarkers of poor prognosis (anti-CCP or RF) were more likely to have a greater response with Orencia treatment than patients testing negative for the biomarkers |
| 2015-06-09 | Bristol-Myers Squibb | Results New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia (abatacept) Plus Methotrexate (MTX) in Patients with Early Moderate to Severe Rheumatoid Arthritis (RA) and Markers of Poor Prognosis bms.com ↗
Shorter disease duration was also associated with a faster onset of clinical response. |
| 2014-11-17 | Bristol-Myers Squibb | Results Analyses from Phase IIIb Study Provide Additional Data in Earlier Use of Orencia (abatacept) Plus Methotrexate (MTX) in Citrullinated Protein (CCP)-Positive Adult Patients with Early Rheumatoid Arthritis (RA) bms.com ↗
Analysis showed treatment with Orencia plus MTX reduced the development of anti-CCP antibodies, an indicator of more severe, persistent, and erosive disease in patients with early rapidly progressing RA |
| 2014-06-10 | Bristol-Myers Squibb | Results AVERT Trial Demonstrates High Rates of DAS-defined Remission with Orencia® (abatacept) in Combination with Methotrexate (MTX) in Adult Patients with Early Rheumatoid Arthritis (RA) bms.com ↗
First line therapy with Orencia plus MTX resulted in 60.9% of patients with early RA achieving DAS-defined remission at month 12 of treatment |
| 2013-06-11 | Bristol-Myers Squibb | Results ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in Year Two Data from Head-to-Head Study in Patients with Moderate to Severe Rheumatoid Arthritis bms.com ↗
Year 2 data shows similar efficacy between ORENCIA plus methotrexate (MTX) and Humira plus MTX, consistent with the year 1 result which demonstrated comparable efficacy based on a non-inferiority endpoint for ACR 20 response |
| 2012-11-12 | Bristol-Myers Squibb | Results New Head-to-Head Patient Reported Outcomes Data for Orencia ® SC (abatacept) vs. Humira® (adalimumab) Presented at the 2012 American College of Rheumatology Annual Scientific Meeting bms.com ↗
At one year, Orencia SC plus MTX was similar to Humira plus MTX in improving patient pain (53.0% and 39.2%), improving patient global assessment (46.1% and 41.2%) and decreasing fatigue (-23.2% and -21.4%). |
| 2012-06-06 | Bristol-Myers Squibb | Results ORENCIA® (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents bms.com ↗
ORENCIA demonstrated comparable efficacy to Humira based on a non-inferiority endpoint for ACR20 response at 1 year |
| 2011-07-29 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Subcutaneous Formulation of ORENCIA® (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) formulation of ORENCIA ® (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). |
| 2010-12-06 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Subcutaneous Formulation of ORENCIA® (abatacept) for Adult Patients with Moderate to Severe Rheumatoid Arthritis bms.com ↗ |
| 2010-11-08 | Bristol-Myers Squibb | Results New Data Show That Subcutaneous Injection of an Investigational Formulation of ORENCIA® (abatacept) Provided Similar Improvements in Disease Activity Compared to Intravenous Administration of ORENCIA bms.com ↗
The ACQUIRE trial met the primary endpoint of non-inferiority of subcutaneous to I.V. ORENCIA as measured by ACR20 score at 6 months. |
| 2009-10-20 | Bristol-Myers Squibb | Results New Data Describe Safety of Subcutaneous Administration of ORENCIA® (abatacept) For Patients with Moderate to Severe Rheumatoid Arthritis bms.com ↗
The study showed that weekly administration of a 125 mg subcutaneous dose of ORENCIA resulted in minimal, transient immunogenicity prior to Month 4 after repeat dosing. |
| 2009-10-19 | Bristol-Myers Squibb | Results ORENCIA® (abatacept) Demonstrated Sustained Clinical Response in a Study of Adult Patients with Moderate to Severe Early Rheumatoid Arthritis (Less Than Two Years Duration) bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced two-year results of a study that supports use of ORENCIA ® (abatacept) for methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration. |
| 2009-08-26 | Bristol-Myers Squibb | Regulatory Updated ORENCIA® (abatacept) Labeling Includes Data to Support Earlier Use in Adult Patients with Moderate to Severe Rheumatoid Arthritis bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that clinical data added to the labeling for ORENCIA ® (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration. |
| 2008-10-27 | Bristol-Myers Squibb | Results Study Results Demonstrate More Patients With Early Erosive Rheumatoid Arthritis Treated With ORENCIA(R) (abatacept) and Methotrexate (MTX) Achieved DAS28 (CRP)-Defined Remission Compared to MTX Alone bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase IIIb study in adult patients with early moderate-to-severe erosive rheumatoid arthritis (RA) who had never received previous methotrexate (MTX) treatment. |
| 2008-10-27 | Bristol-Myers Squibb | Results Data Demonstrate ORENCIA(R) (abatacept) Improves Health-Related Quality of Life, Pain and Sleep Quality in Children With Juvenile Idiopathic Arthritis bms.com ↗
These improvements with ORENCIA were maintained throughout the 10-month study period, during which the first four months included an open-label lead-in period and the last six months comprised a randomized, double-blind, placebo-controlled study. |
| 2008-06-13 | Bristol-Myers Squibb | Results Data from Phase II Exploratory Study Suggest That ORENCIA(R) (abatacept) May Delay Development of Rheumatoid Arthritis in Adults with Undifferentiated Inflammatory Arthritis bms.com ↗ |
| 2008-06-12 | Bristol-Myers Squibb | Results ORENCIA(R) (abatacept) Provided an Increasing Degree of Inhibition of Structural Damage Through Three Years in Adults with Moderate to Severe Rheumatoid Arthritis bms.com ↗ |
| 2008-04-08 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ORENCIA® (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older bms.com ↗ |
All press releases naming this drug 51 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 202 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | abatacept | “Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: \<60 kg Body weight (BW): 500 mg; \>60-100 kg BW: 750...” NCT01638715 ↗190“Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite...” NCT04692493 ↗ “Abatacept (Orencia) is a selective T-cell modulator that blocks a co-stimulatory signal needed to activate T-cells and has an excellent safety profile.” NCT04261023 ↗ “330 subjects will be randomised 1:1:1 to receive a single 125 mg SC dose of abatacept administered as either DRL\_AB or RP or RMP.” NCT06126042 ↗ “The efficacy of abatacept, a selective costimulation modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown.” PMID 22504093 ↗ Apr 2012 “you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form.” NCT01717846 ↗ “Days +5, +14, +30, +60, +90: abatacept (IND) (10mg/kg/day IV)” NCT03128996 ↗ “Abatacept 10 mg/kg/day on the days +5, +14, +28, +60, +90” NCT06475820 ↗ “* Plerixafor GVHD prophylaxis * abatacept * tocilizumab” NCT04000698 ↗ “abatacept 10 mg/kg intravenous (IV) + methotrexate” NCT00122382 ↗ “Methotrexate or leflunomide + abatacept or” NCT02714634 ↗ |
| Known as | ABA | “OBJECTIVE: To determine whether higher serum exposure during subcutaneous (SC) abatacept (ABA) treatment was associated with an increased infection risk in adult patients with...” PMID 39814436 ↗ May 20253“We conducted a prospective randomized clinical trial to investigate the combination of posttransplant cyclophosphamide (PTCy) and abatacept (Aba) for graft-versus-host disease...” PMID 40554429 ↗ Aug 2025 “Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).” PMID 24584926 ↗ Mar 2014 “Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)” NCT00095147 ↗ |
| Known as | Abatacept Injection | “Drug: Abatacept Injection” NCT04120831 ↗ |
| Known as | BMS-188667 | “A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance...” NCT03714022 ↗6“Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate...” NCT00124982 ↗ “Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris” NCT00306878 ↗ “BMS-188667 (Abatacept)” NCT00095173 ↗ “BMS 188667 (Abatacept)” NCT00035529 ↗ “Abatacept (BMS-188667)” NCT00162266 ↗ |
| Known as | CTLA4-IgG4m | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00094380 ↗ |
| Known as | CTLA4Ig | “Abatacept, also known as CTLA4Ig, acts by blocking vital costimulatory signals required for T lymphocytes to be activated.” NCT00482066 ↗4“An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's).” PMID 24323392 ↗ Dec 2013 “Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris” NCT00306878 ↗ “abatacept also known as Orencia also known as CTLA4-Ig” NCT02429934 ↗ “Abatacept (CTLA4-Ig)” NCT05742243 ↗ |
| Known as | Dr. Reddy's Abatacept | “Other Name: Dr. Reddy's Abatacept” NCT06126042 ↗ |
| Known as | KSHB002 | “Test Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA.” NCT06929039 ↗ |
| Known as | Orencia | “Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: \<60 kg Body weight (BW): 500 mg; \>60-100 kg BW: 750...” NCT01638715 ↗17“Orencia® (Abatacept) will be administered once a week for 6 months subcutaneously (injection under the skin) with an option to continue to receive Abatacept weekly injections...” NCT04203875 ↗ “The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment...” NCT02078882 ↗ “Reference Product (B) (US-licensed ORENCIA): 'ORENCIA' (abatacept) injection 125 mg/mL - Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA.” NCT06929039 ↗ “This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).” NCT00886795 ↗ “Abatacept (Orencia) is a selective T-cell modulator that blocks a co-stimulatory signal needed to activate T-cells and has an excellent safety profile.” NCT04261023 ↗ “Abatacept Injection [Orencia] and Proleukin (aldesleukin)” NCT06307301 ↗ “Patients will receive weekly abatacept (Orencia®) s.c.” NCT04106804 ↗ “Abatacept: Orencia 500-1000 mg/month and 125 mg/week” NCT01557374 ↗ “Orencia: Abatacept plus Methotrexate and steroids” NCT01491815 ↗ “Drug: Abatacept (Orencia)” NCT07238712 ↗ |
| Known as | RG2077 | “Participants randomized to the CTLA4-IgG4m Arm will receive a single intravenous infusion of 10 mg/kg CTLA4-IgG4m (RG2077) following the scheduled cyclophosphamide infusion on...” NCT00094380 ↗ |
| Action | Inhibit | “CTLA4Ig, an antagonist of the CD28/B7 costimulatory interaction” PMID 15807196 ↗ 2005 |
| Modality | Other / unclassified | “abatacept, a selective T cell costimulation modulator” PMID 24504810 ↗ Feb 2014 |
| Route | Intravenous | “i.v infusion” NCT00035529 ↗ |
| Target | CD28 | “abatacept blocks the engagement of CD28 with its ligand” NCT03632187 ↗ |