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

Phase IIIB Switching From Intravenous to Subcutaneous Study

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Abatacept

First Posted Date: 2008-04-22

Last Posted Date: 2015-03-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 123

Registration Number: NCT00663702

Locations: 🇺🇸
Rheumatology Associates Of N. Al, P.C., Huntsville, Alabama, United States
🇺🇸
Desert Medical Advances, Palm Desert, California, United States
🇺🇸
Valerius Medical Group &Research Ctr. Of Greater Long Beach, Long Beach, California, United States

and more 16 locations

Methotrexate-Inadequate Response Study

Phase 3

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Subcutaneous (SC) Abatacept
Drug: Intravenous (IV) Abatacept

First Posted Date: 2007-11-16

Last Posted Date: 2015-11-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 2492

Registration Number: NCT00559585

Locations: 🇺🇸
Rheumatic Disease Clinical Research Center, Llc, Houston, Texas, United States
🇺🇸
Accurate Clinical Research, Houston, Texas, United States
🇺🇸
Cincinnati Rheumatic Disease Study Group, Cincinnati, Ohio, United States

and more 67 locations

Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

Phase 2

Conditions: Ankylosing Spondylitis

Interventions: Drug: abatacept

First Posted Date: 2007-11-15

Last Posted Date: 2008-02-26

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 30

Registration Number: NCT00558506

Locations: 🇩🇪
Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany
🇩🇪
Rheumazentrum Ruhrgebiet, Herne, Germany

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

Phase 2

Completed

Conditions: Takayasu's Arteritis
Giant Cell Arteritis

Interventions: Drug: Abatacept
Drug: Placebo

First Posted Date: 2007-11-12

Last Posted Date: 2018-02-26

Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Target Recruit Count: 97

Registration Number: NCT00556439

Locations: 🇺🇸
Hospital for Special Surgery, New York, New York, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Johns Hopkins Medical Center, Baltimore, Maryland, United States

and more 7 locations

Phase IIIB Subcutaneous Abatacept Monotherapy Study

Phase 3

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: abatacept
Drug: Methotrexate (MTX)

First Posted Date: 2007-10-22

Last Posted Date: 2015-03-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 119

Registration Number: NCT00547521

Locations: 🇺🇸
Columbia Arthritis Center, Columbia, South Carolina, United States
🇺🇸
Boulder Medical Center, Boulder, Colorado, United States
🇺🇸
Physicians East, Pa, Greenville, North Carolina, United States

and more 13 locations

Phase IIIB Subcutaneous Missed Dose Study

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept
Drug: Placebo

First Posted Date: 2007-09-24

Last Posted Date: 2015-04-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 270

Registration Number: NCT00533897

Locations: 🇺🇸
Mountain State Clinical Research, Clarksburg, West Virginia, United States
🇺🇸
Wallace Rheumatic Study Center, Los Angeles, California, United States
🇺🇸
New England Research Associates, Llc, Trumbull, Connecticut, United States

and more 11 locations

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

Phase 2

Terminated

Conditions: Psoriatic Arthritis

Interventions: Drug: Placebo
Drug: Abatacept

First Posted Date: 2007-09-24

Last Posted Date: 2012-08-01

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 191

Registration Number: NCT00534313

Locations: 🇺🇸
Desert Medical Advances, Palm Desert, California, United States
🇺🇸
Arthritis Clinic & Carolina Bone & Joint, Pa, Charlotte, North Carolina, United States
🇺🇸
Boling Clinical Trials, Upland, California, United States

and more 17 locations

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept

First Posted Date: 2007-06-08

Last Posted Date: 2013-06-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 217

Registration Number: NCT00484289

Locations: 🇯🇵
Local Institution, Chiba-Shi, Japan

Abatacept in ANCA Associated Vasculitis

Phase 2

Terminated

Conditions: ANCA-associated Vasculitis

Interventions: Drug: Abatacept (Orencia)

First Posted Date: 2007-06-04

Last Posted Date: 2015-05-29

Lead Sponsor: Imperial College London

Target Recruit Count: 7

Registration Number: NCT00482066

Locations: 🇬🇧
Imperial College London, Hammersmith Hospital, London, United Kingdom

Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis

Phase 1

Completed

Conditions: Wegener's Granulomatosis

Interventions: Drug: Abatacept

First Posted Date: 2007-05-02

Last Posted Date: 2016-01-18

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 20

Registration Number: NCT00468208

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Boston University School of Medicine, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic College of Medicine, Rochester, Minnesota, United States

and more 1 locations

Drug Development Updates

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