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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
-

STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

Phase 3
Recruiting
Conditions
Oligoarthritis, Juvenile
Polyarthritis, Juvenile, Rheumatoid Factor Negative
Interventions
Drug: Etanercept
Drug: Methotrexate
Drug: Intra-articular corticosteroid injections
First Posted Date
2018-11-02
Last Posted Date
2024-10-11
Lead Sponsor
Istituto Giannina Gaslini
Target Recruit Count
260
Registration Number
NCT03728478
Locations
🇮🇹

IRCCS Istituto Giannina Gaslini, Genova, GE, Italy

Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

Phase 4
Terminated
Conditions
Gout Attack
Interventions
First Posted Date
2018-08-17
Last Posted Date
2023-10-27
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
5
Registration Number
NCT03636373
Locations
🇺🇸

Rutgers, Robert Wood Johnson Medical School, Clinical Research Center, New Brunswick, New Jersey, United States

Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh

Phase 4
Conditions
Spondyloarthritis
Interventions
First Posted Date
2018-04-20
Last Posted Date
2018-04-23
Lead Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Target Recruit Count
174
Registration Number
NCT03504072
Locations
🇧🇩

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

Phase 3
Active, not recruiting
Conditions
Psoriasis
Interventions
First Posted Date
2018-03-02
Last Posted Date
2024-12-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
120
Registration Number
NCT03451851
Locations
🇩🇪

Universitatsklinikum Carl Gustav Carcus Dresden, Dresden, Germany

🇩🇪

Universitatsklinikum Frankfurt, Frankfurt, Germany

🇨🇦

Kirk Barber Reseach Inc., Calgary, Alberta, Canada

and more 36 locations

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

First Posted Date
2018-01-30
Last Posted Date
2024-06-24
Lead Sponsor
University of Nebraska
Target Recruit Count
400
Registration Number
NCT03414502
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )

Phase 3
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2018-01-18
Last Posted Date
2018-01-23
Lead Sponsor
Gema Biotech S.A.
Target Recruit Count
141
Registration Number
NCT03403140
Locations
🇦🇷

Instituto Medico CER, Bs As, Argentina

Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

Phase 1
Completed
Conditions
Phase 1
Bioequivalence
Interventions
First Posted Date
2017-09-06
Last Posted Date
2018-09-19
Lead Sponsor
AryoGen Pharmed Co.
Target Recruit Count
34
Registration Number
NCT03273088
Locations
🇮🇷

Orchidpharmed PK/PD site, Tehrān, Tehran, Iran, Islamic Republic of

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Etanercept
Device: Autoinjector
First Posted Date
2017-06-21
Last Posted Date
2017-10-13
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
50
Registration Number
NCT03193957
Locations
🇵🇱

AI Centrum Medyczne, Poznań, Poland

Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2017-06-20
Last Posted Date
2017-09-28
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
50
Registration Number
NCT03193203
Locations
🇳🇱

PRA Health Sciences, Groningen, Netherlands

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2017-06-09
Last Posted Date
2024-07-19
Lead Sponsor
University of Alberta
Target Recruit Count
22
Registration Number
NCT03182426
Locations
🇨🇦

University of Alberta, Edmonton, Alberta, Canada

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