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

Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis

Phase 3

Completed

Conditions: Psoriatic Arthritis
Psoriasis

Interventions: Other: Placebo
Drug: Etanercept

First Posted Date: 2006-04-25

Last Posted Date: 2010-12-23

Lead Sponsor: Amgen

Target Recruit Count: 205

Registration Number: NCT00317499

Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

Phase 2

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Biological: IDEC-C2B8 (rituximab)
Drug: Placebo
Drug: Methotrexate
Drug: Etanercept
Drug: Adalimumab
Drug: Methylprednisolone
Dietary Supplement: Folate

First Posted Date: 2006-03-02

Last Posted Date: 2015-09-28

Lead Sponsor: Biogen

Target Recruit Count: 54

Registration Number: NCT00298272

Locations: 🇺🇸
Research Site, Burlington, Vermont, United States
🇺🇸
Research site, Chardon, Ohio, United States

Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists

Completed

Conditions: Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous

Interventions: Drug: etanercept

First Posted Date: 2006-02-17

Last Posted Date: 2014-02-26

Lead Sponsor: Pfizer

Target Recruit Count: 129

Registration Number: NCT00293709

Locations: 🇩🇪
Pfizer Investigational Site, Muenchen, Germany

Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

Phase 2

Terminated

Conditions: End Stage Renal Disease

Interventions: Drug: Placebo
Drug: Etanercept

First Posted Date: 2006-02-17

Last Posted Date: 2021-07-13

Lead Sponsor: Kaysen, George A., M.D., Ph.D.

Target Recruit Count: 10

Registration Number: NCT00293202

Locations: 🇺🇸
University of California, Davis, Medical Center, Sacramento, California, United States

Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

Completed

Conditions: Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous

Interventions: Drug: Etanercept

First Posted Date: 2006-02-17

Last Posted Date: 2014-02-26

Lead Sponsor: Pfizer

Target Recruit Count: 1308

Registration Number: NCT00293722

Locations: 🇩🇪
Pfizer Investigational Site, Toerwang-Samerberg, Germany

Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

Phase 2

Terminated

Conditions: Lichen Planus

Interventions: Drug: Placebo
Drug: Etanercept

First Posted Date: 2006-02-02

Last Posted Date: 2018-03-21

Lead Sponsor: Stanford University

Target Recruit Count: 27

Registration Number: NCT00285779

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Stanford University Medical Center, Stanford, California, United States

and more 9 locations