Abatacept

Generic Name
Abatacept
Brand Names
Orencia
Drug Type
Biotech
Chemical Formula
-
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 tw...

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.
...

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
Associated Therapies
-

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-10-07
Last Posted Date
2013-07-02
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
104
Registration Number
NCT00767325
Locations
🇬🇧

Local Institution, Leeds, North Yorkshire, United Kingdom

Safety Study of Abatacept to Treat Refractory Sarcoidosis

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2008-08-22
Last Posted Date
2020-03-23
Lead Sponsor
University of Chicago
Target Recruit Count
1
Registration Number
NCT00739960
Locations
🇺🇸

The University of Chicago, Chicago, Illinois, United States

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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-06-26
Last Posted Date
2013-07-30
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
13
Registration Number
NCT00705367
Locations
🇨🇳

Local Institution, Shanghai, Shanghai, China

Phase IIIB Switching From Intravenous to Subcutaneous Study

Phase 3
Completed
Conditions
Interventions
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

Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

Phase 2
Conditions
Interventions
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

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

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

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

Phase 2
Terminated
Conditions
Interventions
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

Phase IIIB Subcutaneous Missed Dose Study

Phase 3
Completed
Conditions
Interventions
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

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

Phase 3
Completed
Conditions
Interventions
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

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