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
-

Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

Phase 4
Completed
Conditions
First Posted Date
2007-12-27
Last Posted Date
2007-12-27
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
500
Registration Number
NCT00581165

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

First Posted Date
2007-11-30
Last Posted Date
2015-08-10
Lead Sponsor
Pfizer
Target Recruit Count
834
Registration Number
NCT00565409
Locations
🇬🇧

Pfizer Investigational Site, Dudley, West Midlands, United Kingdom

Study Evaluating the Efficacy and Safety of Etanercept

Phase 4
Completed
Conditions
First Posted Date
2007-10-19
Last Posted Date
2007-10-19
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
40
Registration Number
NCT00546533

Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

Completed
Conditions
Interventions
First Posted Date
2007-10-16
Last Posted Date
2015-05-12
Lead Sponsor
Pfizer
Target Recruit Count
1715
Registration Number
NCT00544557
Locations
🇩🇪

Klinikum Benjamin Franklin, Berlin, Germany

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

First Posted Date
2007-08-24
Last Posted Date
2013-02-04
Lead Sponsor
AstraZeneca
Target Recruit Count
385
Registration Number
NCT00520572
Locations
🇸🇰

Research Site, Piestany, Slovakia

Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2007-07-31
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
1
Registration Number
NCT00509600
Locations
🇺🇸

UT MD . Anderson Cancer Center, Houston, Texas, United States

Observational Trial With Enbrel

Completed
Conditions
Interventions
First Posted Date
2007-06-20
Last Posted Date
2014-08-01
Lead Sponsor
Pfizer
Target Recruit Count
4945
Registration Number
NCT00488475
Locations
🇩🇪

Pfizer Investigational Site, Muenster, NRW, Germany

A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
First Posted Date
2007-06-08
Last Posted Date
2007-12-05
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
80
Registration Number
NCT00484237

Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

First Posted Date
2007-05-22
Last Posted Date
2016-05-16
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
18
Registration Number
NCT00477191
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

Phase 4
Completed
Conditions
First Posted Date
2007-04-09
Last Posted Date
2008-03-13
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
40
Registration Number
NCT00458185
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