Orencia

(Abatacept)

ApprovedProtein / enzyme

Abatacept is used to treat rheumatoid arthritis and other autoimmune diseases by calming down an overactive immune system that causes joint pain and inflammation.[2] Orencia is currently approved and in use across 22 indications[4].[1]

Orencia is one of 395 small molecule programs targeting Interstitial Lung Disease. It is currently in Approved.

Indications

179

Total Trials

Active Trials

394

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Interstitial Lung DiseaseRecruiting

Giant Cell ArteritisRecruiting

Sickle Cell DiseaseRecruiting

Juvenile DermatomyositisActive, not recruiting

Pemphigus VulgarisActive, not recruiting

LupusUnknown

Immune System DiseaseUnknown

Lung DiseaseActive, not recruiting

Hepatitis BActive, not recruiting

Rheumatic DiseaseRecruiting

Interstitial Lung DiseasePhase 2

Recruiting

Giant Cell ArteritisPhase 3

Recruiting

Sickle Cell DiseasePhase 2

Recruiting

Juvenile DermatomyositisApproved

Active, not recruiting

Pemphigus VulgarisApproved

Active, not recruiting

LupusPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Lung DiseasePreclinical

Active, not recruiting

Hepatitis BPreclinical

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Orencia

Bristol-Myers Squibb

Approved

47 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Nsaids

Roche

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Myeloid Malignancies

NCT07238712

Phase 1Recruiting

Hematopoietic Cell Transplantation

NCT06008808

Phase 1/2Recruiting

Thalassemia

NCT05426252

Q1 2027

Phase 2Active, not recruiting

Prevention

NCT05621759

Phase 2Active, not recruiting

Acute

NCT03924401

Q3 2027

Phase 3Active, not recruiting

Rheumatoid Arthritis

NCT04909801

Clinical

Trials by Indication[1]

Rheumatoid Arthritis47 trials

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02504268·994 enrolled

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Completed· AbbVie logo

AbbVie·Phase 3·NCT03086343·657 enrolled

Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02598466·69 enrolled

Show 44 more trials

A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer··NCT06418529·21,340 enrolled

Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

Completed·UUniversity Hospital, Montpellier·N/A·NCT02547493·80 enrolled

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00122382·1,052 enrolled

Effects of Abatacept on Myocarditis in Rheumatoid Arthritis

Terminated·—·Phase 4·NCT03619876·11 enrolled

Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00048581·738 enrolled

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)

Completed· Novartis logo

Novartis·Phase 3·NCT01350804·551 enrolled

Rheumatoid Arthritis Memory B Cells and Abatacept

Completed·NNYU Langone Health·Phase 4·NCT03652961·25 enrolled

Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00989235·108 enrolled

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

Unknown status·VVastra Gotaland Region··NCT03440892·2,500 enrolled

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00484289·217 enrolled

APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

Unknown status·—·Phase 2·NCT03084419·30 enrolled

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00162201·16 enrolled

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00095147·431 enrolled

Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT01000441·300 enrolled

A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

Completed· Astellas logo

Astellas··NCT01339481·26 enrolled

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02037737·153 enrolled

Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00279760·210 enrolled

A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00345748·194 enrolled

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Completed·JJulia Brown·Phase 4·NCT01295151·122 enrolled

EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 4·NCT03669367·70 enrolled

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

Recruiting·UUniversity Hospital, Montpellier·Phase 3·NCT05428488·220 enrolled

Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

Completed·SSt George's, University of London·Phase 4·NCT04255134·18 enrolled

Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

Completed·AArthritis & Rheumatic Disease Specialties Research·Phase 3·NCT01351480·34 enrolled

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT02722694·360 enrolled

Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage

Completed·OOrrin M Troum, M.D. and Medical Associates·Phase 2/3·NCT01333878·12 enrolled

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT01001832·118 enrolled

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

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04909801·338 enrolled

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Completed· Astellas logo

Astellas·Phase 4·NCT03737708·21 enrolled

A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis

Completed·UUniversity of Washington·Phase 4·NCT03882008·25 enrolled

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01142726·511 enrolled

Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00124449·56 enrolled

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT02557100·80 enrolled

A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00767325·104 enrolled

Inhibition of Co-Stimulation in Rheumatoid Arthritis

Unknown status·NNHS Greater Glasgow and Clyde·Phase 4·NCT02652273·25 enrolled

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00095173·214 enrolled

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00124982·1,286 enrolled

Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Completed·UUniversity of California, Los Angeles·Phase 3·NCT01299961·25 enrolled

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)

Completed·LLeiden University Medical Center·Phase 4·NCT03492658·46 enrolled

A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00409838·113 enrolled

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00254293·87 enrolled

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00048568·1,250 enrolled

Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis

Unknown status·ZZhejiang Provincial People's Hospital·Phase 3·NCT05451615·90 enrolled

A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00420199·50 enrolled

TACE10 trials

Expanded Access for Abatacept

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05170672

Post-marketing Study Assessing the Long-Term Safety of Abatacept

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02169544·100,000 enrolled

The Study of Abatacept in Combination With Etanercept

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00162279·141 enrolled

Show 7 more trials

Study in ALS With Abatacept & IL-2

Active, not recruiting·TThe Methodist Hospital Research Institute·Phase 1·NCT06307301·5 enrolled

IL-2 Plus Abatacept in FTD

Recruiting·TThe Methodist Hospital Research Institute·Phase 1·NCT06395038·10 enrolled

A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05981976·174 enrolled

Long Term Experience With Abatacept in Routine Clinical Practice

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02109666·2,364 enrolled

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

Completed·OOklahoma Medical Research Foundation·Phase 2·NCT02270957·66 enrolled

Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01221636

Abatacept Post-marketing Clinical Study in Japan

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01758198·405 enrolled

COVID-195 trials

Abatacept for Patients With COVID-19 and Respiratory Distress

Withdrawn·—·Phase 1/2·NCT04477642

Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04472494·61 enrolled

COVID-19 VaccinE Response in Rheumatology Patients

Completed·JJeffrey Curtis·Phase 4·NCT05080218·841 enrolled

Show 2 more trials

Immune Modulators for Treating COVID-19

Completed·DDaniel Benjamin·Phase 3·NCT04593940·1,971 enrolled

Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

Completed·UUniversity of Minnesota·Approved·NCT05822583·285 enrolled

Psoriatic Arthritis4 trials

Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00534313·191 enrolled

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 4·NCT04106804·20 enrolled

Show 1 more trial

Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01860976·489 enrolled

Drug Repurposing3 trials

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept

Completed·—··NCT04529863·30,432 enrolled

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - TNFi vs Abatacept

Completed·—··NCT04529902·63,013 enrolled

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept

Completed·—··NCT04529876·29,464 enrolled

86 more indications

Psoriasis Vulgaris3 trials

A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00277225·32 enrolled

Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01999868·108 enrolled

Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00306878·45 enrolled

Methotrexate3 trials

Methotrexate-Inadequate Response Autoinjector Device Sub Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01844895·120 enrolled

Methotrexate-Inadequate Response Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00559585·2,492 enrolled

Abatacept With Methotrexate- Phase IIB

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00162266·524 enrolled

Giant Cell Arteritis3 trials

Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 2·NCT00556439·97 enrolled

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03192969

A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)

Recruiting·UUniversity of Pennsylvania·Phase 3·NCT04474847·78 enrolled

Single Dose3 trials

Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01890473·356 enrolled

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT02805010·22 enrolled

Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00705367·13 enrolled

Prophylaxis3 trials

Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors

Not yet recruiting·PPeking University People's Hospital·Phase 1/2·NCT06279494·6 enrolled

HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT

Recruiting·—·Phase 1·NCT06731504·10 enrolled

Abatacept as GVHD Prophylaxis Phase 2

Completed·—·Phase 2·NCT01743131·186 enrolled

Sickle Cell Disease3 trials

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

Completed·MMonica Bhatia·Phase 1·NCT02867800·24 enrolled

Recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Preclinical·NCT07599176·90 enrolled

Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT07616154·45 enrolled

Alopecia Areata2 trials

A Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata

Withdrawn·—·Phase 2·NCT01917058

An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata

Completed·—·Phase 2·NCT02018042·15 enrolled

Tocilizumab2 trials

Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept

Terminated·—·Phase 4·NCT02353780·10 enrolled

Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders

Unknown status·LLille Catholic University·Phase 4·NCT03227419·224 enrolled

Systemic Sclerosis2 trials

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

Completed·—·Phase 2·NCT02161406·88 enrolled

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

Completed·SStanford University·Phase 1/2·NCT00442611·10 enrolled

Prevention2 trials

Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

Active, not recruiting·NNYU Langone Health·Phase 2·NCT05621759·27 enrolled

Abatacept s.c. for aGVHD Prevention in Haplo-HCT

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 1/2·NCT04686929·29 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03733067

A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome

Completed·NNYU Langone Health·Phase 1·NCT01693640·3 enrolled

Lupus Nephritis2 trials

Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00774852·137 enrolled

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT00430677·423 enrolled

Uveitis2 trials

Abatacept in the Treatment of Uveitis

Completed·OOregon Health and Science University·Phase 2·NCT01279954·10 enrolled

Abatacept in Patients With Birdshot HLA A29 Uveitis

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT03871361·15 enrolled

Arthritis2 trials

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study

Withdrawn·TThe Cleveland Clinic·Phase 2·NCT02027298

Abatacept for SLE Arthritis (IM101-330)

Terminated·UUniversity of California, Los Angeles·Phase 1/2·NCT02429934·28 enrolled

Dermatomyositis2 trials

Abatacept Treatment in Polymyositis and Dermatomyositis

Completed·KKarolinska Institutet·Phase 2·NCT01315938·20 enrolled

An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 1·NCT04946669·20 enrolled

Interstitial Lung Disease2 trials

Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease

Completed·RRohit Aggarwal, MD·Phase 2·NCT03215927·20 enrolled

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Phase 2·NCT04925375·38 enrolled

Systemic Lupus Erythematosus2 trials

Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00119678·183 enrolled

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04186871·119 enrolled

Juvenile Idiopathic Arthritis2 trials

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

Completed·—·Phase 3·NCT03841357·121 enrolled

Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01835470·23 enrolled

Lung Disease1 trial

Rituximab and Abatacept Effectiveness in Differential Treatment of Interstitial Lymphocytic Lung Disease in Children With Primary Immunodeficiencies.

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology··NCT04572620·30 enrolled

Ulcerative Colitis1 trial

A Study of Abatacept in Patients With Active Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00410410·591 enrolled

Intravenous1 trial

Phase IIIB Switching From Intravenous to Subcutaneous Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00663702·123 enrolled

Chronic Graft Versus Host Disease1 trial

Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)

Completed·—·Phase 1·NCT01954979·56 enrolled

Monotherapy1 trial

Phase IIIB Subcutaneous Abatacept Monotherapy Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00547521·119 enrolled

Stem Cell Transplantation1 trial

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

Completed·—·Phase 2·NCT03680092·43 enrolled

Adalimumab1 trial

Abatacept Versus Adalimumab Head-to-Head

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00929864·869 enrolled

Alopecia Totalis1 trial

Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis

Withdrawn·JJulian M. Mackay-Wiggan·Phase 2·NCT01314495

Focal Segmental Glomerulosclerosis1 trial

Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02592798·36 enrolled

Multiple Sclerosis1 trial

A Cooperative Clinical Study of Abatacept in Multiple Sclerosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01116427·65 enrolled

Granuloma1 trial

Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis

Completed·UUniversity of Pennsylvania·Phase 1/2·NCT00468208·20 enrolled

Hematopoietic Cell Transplantation1 trial

Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Recruiting·WWashington University School of Medicine·Phase 1·NCT06008808·41 enrolled

Immunogenicity1 trial

Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects

Completed·KKashiv BioSciences, LLC·Phase 1·NCT06929039·300 enrolled

Islet Transplantation1 trial

Islet Transplantation Using Abatacept

Completed·EEmory University·Phase 2·NCT00276250·5 enrolled

Bone Marrow Transplant1 trial

Bone Marrow Transplant With Abatacept for Non-Malignant Diseases

Completed·EEmory University·Phase 1·NCT01917708·10 enrolled

Phase II1 trial

Phase IIIB Subcutaneous Missed Dose Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00533897·270 enrolled

Immunosuppression1 trial

Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT

Completed·—·Phase 2·NCT01012492·11 enrolled

Ankylosing Spondylitis1 trial

Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

Unknown status·—·Phase 2·NCT00558506·30 enrolled

Primary Biliary Cirrhosis1 trial

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

Completed·—·Phase 4·NCT02078882·16 enrolled

Vitiligo1 trial

Open-label Pilot Study of Abatacept for the Treatment of Vitiligo

Unknown status·—·Phase 1·NCT02281058·10 enrolled

Tics1 trial

A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03714022·140 enrolled

Relapsing Polychondritis1 trial

Study on the Safety of Abatacept in Relapsing Polychondritis

Completed·—·Phase 1·NCT01272856·4 enrolled

Type 1 Diabetes1 trial

Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes

Completed·MMelbourne Health·Phase 2·NCT05742243·68 enrolled

Vascular Dysfunction1 trial

Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach

Withdrawn·UUniversity of Utah·Phase 1·NCT04344873

Renal Transplant Recipients1 trial

Subcutaneous Abatacept in Renal Transplant Recipients

Completed·IIdelberto Badell·Phase 1·NCT05975450·14 enrolled

Vaccination1 trial

Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00279734·80 enrolled

Pemphigus Vulgaris1 trial

A Study to Evaluate Efficacy and Safety of Abatacept in Participants of Pemphigus Vulgaris (PV)

Unknown status·TTongji Hospital·Phase 4·NCT05303272·60 enrolled

Primary Sjögren's Syndrome1 trial

Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome

Completed·UUniversity Medical Center Groningen·Phase 3·NCT02067910·80 enrolled

MPA1 trial

Comparability DE vs CD-CHO1

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00277199·30 enrolled

Juvenile Dermatomyositis1 trial

Abatacept in Juvenile Dermatomyositis

Completed·GGeorge Washington University·Phase 4·NCT02594735·10 enrolled

Treatment1 trial

Treatment Tapering in JIA With Inactive Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02840175·62 enrolled

Hypertension1 trial

Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation

Terminated·VVanderbilt University Medical Center·Phase 2·NCT02232880·1 enrolled

Hepatitis B1 trial

Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background

Withdrawn·UUniversity of California, Los Angeles·N/A·NCT02053727

Thalassemia1 trial

Thal-Fabs: Reduced Toxicity Conditioning for High Risk Thalassemia

Recruiting·TThe Hospital for Sick Children·Phase 1/2·NCT05426252·20 enrolled

Biomarkers1 trial

New Biomarkers for Diagnosis and Follow-up of Patients With LRBA or CTLA4 Deficiencies

Unknown status·MMarmara University··NCT04377867·30 enrolled

Urticaria1 trial

Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy

Completed·JJohns Hopkins University·Phase 1/2·NCT00886795·4 enrolled

Idiopathic Inflammatory Myopathy1 trial

Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02971683·149 enrolled

Arthralgia1 trial

Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT02778906·98 enrolled

Acute1 trial

Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant

Active, not recruiting·EEmory University·Phase 2·NCT03924401·30 enrolled

Myeloid Malignancies1 trial

Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor

Recruiting·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT07238712·60 enrolled

Myasthenia Gravis1 trial

Trial of Orencia in Patients With Myasthenia Gravis

Terminated·JJohns Hopkins University·Phase 1·NCT03059888·6 enrolled

Biologics1 trial

Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01439204·223 enrolled

Tolerance1 trial

TOLERA: Tolerance Enhancement in RA

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 2·NCT04120831·20 enrolled

Vasculitis1 trial

Abatacept in ANCA Associated Vasculitis

Terminated·IImperial College London·Phase 2·NCT00482066·7 enrolled

Polymyalgia Rheumatica1 trial

Abatacept in earLy Onset Polymyalgia Rheumatica: Study ALORS

Unknown status·UUniversity Hospital, Brest·Phase 3·NCT03632187·34 enrolled

Efficacy1 trial

Real-world Clinical Efficacy of Abatacept in the T3 Data Registry

Completed·AArthritis Northwest PLLC··NCT01555879·200 enrolled

Polyarticular Juvenile Idiopathic Arthritis1 trial

Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01844518·219 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies

Recruiting·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2/3·NCT07366801·64 enrolled

Atopic Asthma1 trial

The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics

Completed·WWashington University School of Medicine·Phase 2·NCT00784459·24 enrolled

IgG4 Related Disease1 trial

Safety and Efficacy of Abatacept in IgG4-Related Disease

Completed·MMassachusetts General Hospital·Phase 2·NCT03669861·10 enrolled

Crohn's Disease1 trial

A Study of Abatacept in Patients With Active Crohn's Disease

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00406653·451 enrolled

Kidney Transplant1 trial

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05917522·800 enrolled

Graft Versus Host Disease1 trial

Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis

Recruiting·—·Phase 2·NCT04380740·160 enrolled

Sarcoidosis1 trial

Safety Study of Abatacept to Treat Refractory Sarcoidosis

Terminated·UUniversity of Chicago·Phase 2·NCT00739960·1 enrolled

Granulomatosis with Polyangiitis1 trial

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Completed·UUniversity of South Florida·Phase 3·NCT02108860·65 enrolled

Adjuvant Treatment1 trial

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

Completed·PPhilippe Bégin·Phase 2·NCT04872218·14 enrolled

Graft-versus-host-disease (GVHD)1 trial

Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)

Active, not recruiting·NNorthwell Health·Phase 1/2·NCT05289167·74 enrolled

Efficacy and Safety1 trial

A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02915159·250 enrolled

Multiple Myeloma1 trial

Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT03457142·15 enrolled

Renal Transplant Recipient1 trial

Late Abatacept Conversion in Kidney Transplant Recipients Receiving Belatacept: a Prospective, Randomized Controlled Non-inferiority Trial. IM101-884

Completed·EEmory University·Phase 2·NCT04955366·87 enrolled

Acute Myelogenous Leukemia1 trial

ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis

Suspended·LLeland Metheny·Phase 2·NCT06680661·20 enrolled

Type 1 Diabetes Mellitus1 trial

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

Active, not recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT03929601·74 enrolled

Lymphoma, T Cell, Peripheral1 trial

A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Suspended·NNational Cancer Institute (NCI)·Phase 1·NCT07388563·20 enrolled

Myocarditis Acute1 trial

AbatacepT foR ImmUne Checkpoint Inhibitor Associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in ICI Myocarditis

Recruiting·MMassachusetts General Hospital·Phase 3·NCT05335928·390 enrolled

Polyarticular Course Juvenile Idiopathic Arthritis1 trial

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Recruiting·DDuke University·Phase 3·NCT06654882·400 enrolled

Myocarditis1 trial

AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05195645·21 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Unspecified1 trial

Early Markers of Disease and Response to Therapy

Completed·—·Phase 1·NCT04118153·60 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 2005

ORENCIA

NDA BLA125118

Dec 23, 2005

ORENCIA

BLA BLA125118

Dec 12, 2006

ORENCIA

NDA BLA125118

Mar 13, 2007

ORENCIA

NDA BLA125118

Mar 21, 2008

ORENCIA

NDA BLA125118

Apr 7, 2008

ORENCIA

NDA BLA125118

Aug 25, 2009

ORENCIA

NDA BLA125118

Jun 23, 2011

ORENCIA

NDA BLA125118

Jul 29, 2011

ORENCIA

NDA BLA125118

Aug 18, 2011

ORENCIA

NDA BLA125118

Feb 17, 2012

ORENCIA

NDA BLA125118

Dec 20, 2013

ORENCIA

NDA BLA125118

Dec 30, 2014

ORENCIA

NDA BLA125118

Jun 7, 2016

ORENCIA

NDA BLA125118

Mar 30, 2017

ORENCIA

NDA BLA125118

Jun 30, 2017

ORENCIA

NDA BLA125118

Mar 21, 2019

ORENCIA

NDA BLA125118

Jun 17, 2020

ORENCIA

NDA BLA125118

Jun 17, 2020

ORENCIA

NDA BLA125118

Jun 17, 2020

ORENCIA

NDA BLA125118

Dec 15, 2021

ORENCIA

NDA BLA125118

Apr 13, 2022

ORENCIA

NDA BLA125118

Oct 30, 2023

ORENCIA

NDA BLA125118

Jan 19, 2024

ORENCIA

NDA BLA125118

May 29, 2024

ORENCIA

NDA BLA125118

Sources

References

[1]
ClinicalTrials.gov — 179 trial records for Abatacept. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Orencia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Abatacept compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Abatacept. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125118). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: T-Lymphocyte Activation Antigen CD80 Inhibitor; T-Lymphocyte Activation Antigen CD86 Inhibitor[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb