Abatacept

Generic Name: Abatacept

Brand Names: Orencia

Drug Type: Biotech

CAS Number: 332348-12-6

Unique Ingredient Identifier: 7D0YB67S97

Background: Abatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Structurally, abatacept is a glycosylated fusion protein with a MALDI-MS molecular weight of 92,300 Da and it is a homodimer of two homologous polypeptide chains of 357 amino acids each. It is produced through recombinant DNA technology in mammalian CHO cells. The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes. Although approved for the treatment of rheumatoid arthritis, Repligen has entered a slightly different formulation of CTLA4-Ig into clinical trials (RG2077).

Indication: Abatacept is indicated in adult patients for the treatment of moderately-to-severely active rheumatoid arthritis and for the treatment of active psoriatic arthritis. In patients two years of age and older, abatacept is also indicated for the treatment of moderately-to-severely active juvenile idiopathic arthritis.

Abatacept is also indicated for the prophylaxis of acute graft-versus-host disease, in combination with methotrexate and a calcineurin inhibitor such as tacrolimus, in patients two years of age and older who are undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.

Associated Conditions: Acute Graft-Versus-Host Disease (GVHD), Moderate to Severe Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Polyarticular juvenile rheumatoid arthritis, chronic or unspecified, Psoriatic Arthritis

Clinical Trials

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

Phase 3

Completed

Conditions: Autoimmune Necrotizing Myopathy
Juvenile Myositis Above the Age of 18
Overlap Myositis
Polymyositis
Dermatomyositis

Interventions: Drug: Abatacept subcutaneous
Drug: Placebo

First Posted Date: 2016-11-23

Last Posted Date: 2023-10-30

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 149

Registration Number: NCT02971683

Locations: 🇲🇽
Local Institution - 0047, San Luis Potosi, Mexico
🇸🇪
Local Institution - 0037, Stockholm, Sweden
🇺🇸
Local Institution - 0018, Fort Lauderdale, Florida, United States

and more 76 locations

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

Phase 1

Completed

Conditions: Sickle Cell Disease
Graft Versus Host Disease

Interventions: Drug: Diphenhydramine
Drug: Acetaminophen
Drug: Methylprednisolone
Drug: Meperidine
Drug: Alemtuzumab
Drug: Thymoglobulin
Drug: Fludarabine
Drug: Melphalan
Drug: Thiotepa
Drug: Cyclosporine
Drug: Tacrolimus
Drug: Methotrexate
Drug: Abatacept
Procedure: Marrow infusion
Drug: Sirolimus
Drug: Mycophenolate Mofetil

First Posted Date: 2016-08-16

Last Posted Date: 2024-06-13

Lead Sponsor: Monica Bhatia

Target Recruit Count: 24

Registration Number: NCT02867800

Locations: 🇺🇸
North Carolina Cancer Hospital, Chapel Hill, North Carolina, United States
🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States

and more 4 locations

Treatment Tapering in JIA With Inactive Disease

Phase 3

Completed

Conditions: Juvenile Idiopathic Arthritis

Interventions: Drug: etanercept
Drug: adalimumab
Drug: Abatacept
Drug: Tocilizumab

First Posted Date: 2016-07-21

Last Posted Date: 2021-04-01

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 62

Registration Number: NCT02840175

Locations: 🇫🇷
Necker Children's Hospital, Paris, France

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

Phase 1

Conditions: Rheumatoid Arthritis (RA)

Interventions: Other: Placebo
Drug: Abatacept

First Posted Date: 2016-06-17

Last Posted Date: 2016-12-06

Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Target Recruit Count: 22

Registration Number: NCT02805010

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

Phase 3

Completed

Conditions: Arthralgia
Arthritis

Interventions: Drug: Placebo
Drug: Abatacept

First Posted Date: 2016-05-20

Last Posted Date: 2020-03-10

Lead Sponsor: University of Erlangen-Nürnberg Medical School

Target Recruit Count: 98

Registration Number: NCT02778906

Locations: 🇩🇪
Charite Berlin, Berlin, Germany
🇩🇪
Clinic Burghausen, Burghausen, Germany
🇩🇪
University Clinic Erlangen, Erlangen, Germany

and more 6 locations

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

Phase 3

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Subcutaneous(SC) Abatacept
Other: Placebo
Drug: Methotrexate

First Posted Date: 2016-03-30

Last Posted Date: 2016-09-13

Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Target Recruit Count: 360

Registration Number: NCT02722694

Locations: 🇨🇳
Peking union medical college hospital, Beijing, Beijing, China

Inhibition of Co-Stimulation in Rheumatoid Arthritis

Phase 4

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Abatacept

First Posted Date: 2016-01-11

Last Posted Date: 2016-01-12

Lead Sponsor: NHS Greater Glasgow and Clyde

Target Recruit Count: 25

Registration Number: NCT02652273

Locations: 🇬🇧
NHS Greater Glasgow and Clyde, Glasgow, United Kingdom
🇬🇧
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom