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

Study of TNF-Antagonism in the Metabolic Syndrome (II)

Not Applicable

Completed

Conditions: Metabolic Syndrome

Interventions: Drug: Placebo
Drug: Etanercept

First Posted Date: 2006-12-19

Last Posted Date: 2010-12-02

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 40

Registration Number: NCT00413400

Locations: 🇺🇸
MGH, Boston, Massachusetts, United States

Study of TNF-Antagonism in Metabolic Syndrome

Not Applicable

Completed

Conditions: Metabolic Syndrome

Interventions: Drug: Etanercept
Drug: Placebo

First Posted Date: 2006-12-08

Last Posted Date: 2008-05-28

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 56

Registration Number: NCT00409318

Locations: 🇺🇸
MGH, Boston, Massachusetts, United States

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept
Drug: methotrexate
Drug: Sulfasalazine
Drug: Placebo, triple
Drug: Hydroxychloroquine
Drug: Placebo, etanercept

First Posted Date: 2006-11-30

Last Posted Date: 2013-12-03

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 353

Registration Number: NCT00405275

Locations: 🇺🇸
VA Medical Center, Loma Linda, Loma Linda, California, United States
🇺🇸
VA Pittsburgh Health Care System, Pittsburgh, Pennsylvania, United States
🇺🇸
Geisinger Medical Group - State College, State College, Pennsylvania, United States

and more 34 locations

Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

Phase 3

Completed

Conditions: Active Rheumatoid Arthritis

First Posted Date: 2006-10-27

Last Posted Date: 2023-12-13

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

Target Recruit Count: 615

Registration Number: NCT00393471

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept

First Posted Date: 2006-08-08

Last Posted Date: 2013-09-17

Lead Sponsor: Amgen

Target Recruit Count: 14

Registration Number: NCT00361634

Locations: 🇬🇧
Research Site, London, United Kingdom

16.0040 Ankylosing Spondylitis Study

Phase 3

Completed

Conditions: Ankylosing Spondylitis

Interventions: Drug: Etanercept

First Posted Date: 2006-07-26

Last Posted Date: 2013-05-14

Lead Sponsor: Amgen

Target Recruit Count: 257

Registration Number: NCT00356356

A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis

Phase 3

Completed

Conditions: Palmoplantaris Pustulosis

Interventions: Drug: Placebo comparator
Drug: Etanercept

First Posted Date: 2006-07-17

Last Posted Date: 2011-09-09

Lead Sponsor: Innovaderm Research Inc.

Target Recruit Count: 15

Registration Number: NCT00353119

Locations: 🇨🇦
Innovaderm Research Incorporated, Montreal, Quebec, Canada
🇨🇦
Centre de Recherche Dermatologique du Québec métropolitain, Quebec, Canada