Etanercept

Generic Name: Etanercept

Brand Names: Enbrel, Eticovo, Benepali, Erelzi, Nepexto

Drug Type: Biotech

Chemical Formula: -

CAS Number: 185243-69-0

Unique Ingredient Identifier: OP401G7OJC

Background: Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids. It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA).

Indication: Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and in chronic moderate to severe plaque psoriasis in patients 4 years of age and older. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis and Juvenile Psoriatic Arthritis in those aged 2 years and older. Etanercept is also used to manage the symptoms of psoriatic arthritis and ankylosing spondylitis.

Associated Conditions: Active Juvenile Psoriatic Arthritis, Ankylosing Spondylitis (AS), Graft-versus-host Disease (GVHD), Polyarticular Juvenile Idiopathic Arthritis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriatic Arthritis, Pyoderma Gangrenosum, Rheumatoid Arthritis, Severe Plaque psoriasis, Stevens-Johnson Syndrome, Chronic, severe Psoriatic Arthritis, Moderate Plaque psoriasis, Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis

Associated Therapies: -

Clinical Trials

Etanercept for the Treatment of Lupus Nephritis

Phase 2

Terminated

Conditions: Lupus Nephritis

Interventions: Drug: Etanercept
Drug: Placebo
Drug: Lupus Treatment- Standard of Care

First Posted Date: 2007-03-14

Last Posted Date: 2013-02-12

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 1

Registration Number: NCT00447265

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
University of California at San Francisco, San Francisco, California, United States
🇺🇸
Feinstein Institute for Medical Research NS-L1J Health System, Manhasset, New York, United States

and more 3 locations

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Etanercept
Drug: Methotrexate

First Posted Date: 2007-03-09

Last Posted Date: 2011-08-15

Lead Sponsor: Pfizer

Target Recruit Count: 550

Registration Number: NCT00445770

Locations: 🇯🇵
Pfizer Investigational Site, Toyama, Japan

Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

First Posted Date: 2007-03-07

Last Posted Date: 2007-12-13

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Target Recruit Count: 150

Registration Number: NCT00443950

Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis

Phase 4

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Infliximab
Drug: Etanercept

First Posted Date: 2007-02-07

Last Posted Date: 2009-03-11

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 40

Registration Number: NCT00432406

Locations: 🇨🇳
Prince of Wales Hospital, Hong Kong, China

An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Phase 3

Completed

Conditions: Ankylosing Spondylitis

First Posted Date: 2007-01-15

Last Posted Date: 2007-01-15

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Target Recruit Count: 84

Registration Number: NCT00421980

Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

Phase 4

Completed

Conditions: Spondylarthropathies, Enthesitis

Interventions: Drug: Etanercept
Other: Placebo

First Posted Date: 2007-01-11

Last Posted Date: 2010-07-20

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Target Recruit Count: 24

Registration Number: NCT00420303

Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation (BMT CTN 0403)

Phase 3

Completed

Conditions: Idiopathic Pneumonia Syndrome
Pneumonia

Interventions: Drug: Etanercept
Drug: Placebo plus corticosteroid

First Posted Date: 2007-01-11

Last Posted Date: 2021-11-01

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 37

Registration Number: NCT00421174

Locations: 🇺🇸
University of Florida College of Medicine (Shands), Gainesville, Florida, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 9 locations