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 in New Onset Type 1 Diabetes

Phase 1

Completed

Conditions: Type 1 Diabetes

Interventions: Drug: Etanercept
Drug: Placebo

First Posted Date: 2008-08-08

Last Posted Date: 2023-04-28

Lead Sponsor: State University of New York at Buffalo

Target Recruit Count: 18

Registration Number: NCT00730392

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

Withdrawn

Conditions: Rheumatoid Arthritis

Interventions: Drug: infliximab
Drug: etanercept
Drug: adalimumab

First Posted Date: 2008-07-29

Last Posted Date: 2015-06-01

Lead Sponsor: Merck Sharp & Dohme LLC

Registration Number: NCT00724672

A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept
Drug: AZD5672
Drug: Placebo

First Posted Date: 2008-07-11

Last Posted Date: 2011-10-03

Lead Sponsor: AstraZeneca

Target Recruit Count: 373

Registration Number: NCT00713544

Locations: 🇺🇦
Research Site, Simferopol, Ukraine

Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Etanercept

First Posted Date: 2008-06-25

Last Posted Date: 2009-07-28

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

Target Recruit Count: 60

Registration Number: NCT00705042

Evaluation of The Efficacy And Safety of Intra-Articular Etanercept in Patients With Refractory Knee Joint Synovitis

Phase 2

Completed

Conditions: Persistent Knee Joint Synovitis

First Posted Date: 2008-05-16

Last Posted Date: 2008-05-16

Lead Sponsor: University of Padova

Target Recruit Count: 31

Registration Number: NCT00678782

Locations: 🇮🇹
Centro Multidisciplinare di Day Surgery, Azienda Ospedaliera di Padova, Ospedale Busonera, via Gattamelata 64, Padova, Italy

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Phase 4

Completed

Conditions: Plaque Psoriasis
Psoriasis

Interventions: Drug: Etanercept

First Posted Date: 2008-04-21

Last Posted Date: 2012-04-23

Lead Sponsor: Pfizer

Target Recruit Count: 273

Registration Number: NCT00663052

Locations: 🇹🇭
Pfizer Investigational Site, Bangkok, Thailand

Safety and Efficacy of Combining nbUVB to Etanercept in Patients

Phase 4

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: Etanercept
Device: nbUVB

First Posted Date: 2008-03-21

Last Posted Date: 2011-09-09

Lead Sponsor: Innovaderm Research Inc.

Target Recruit Count: 99

Registration Number: NCT00640393

Locations: 🇨🇦
Bank on Beauty, Niagara Falls, Ontario, Canada
🇨🇦
Innovaderm Research Inc., Montreal, Quebec, Canada
🇨🇦
Winnipeg Clinic, Winnipeg, Manitoba, Canada

and more 7 locations