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Last Updated: June 4, 2020

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CLINICAL TRIALS PROFILE FOR ENBREL

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Biosimilar Clinical Trials for ENBREL

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT01891864 Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel Completed Sandoz Phase 3 2013-06-01 The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.
NCT03273088 Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects Completed AryoGen Pharmed Co. Phase 1 2016-12-04 This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept. The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax. The secondary objectives of the study are: To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ENBREL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000433 Blocking Tumor Necrosis Factor in Ankylosing Spondylitis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 1999-10-01 The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. It blocks the action of tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid arthritis, and other inflammatory conditions. We will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.
NCT00001893 Study of TNFR:Fc (Enbrel) in the Treatment of Asthma Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1999-08-01 The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen bronchoprovocation model of atopic asthma. The goal of this study is to assess whether inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind, placebo-controlled trial design. TNF bioactivity will be inhibited via systemic administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the utility of anti-TNF therapy for patients with asthma.
NCT00001901 Etanercept to Treat Wegener's Granulomatosis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1999-02-01 This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. Generally, the greater the disease involvement, the more life-threatening it is. Standard treatment is a combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate. However, many patients treated with this regimen have a disease relapse, and others cannot take these drugs because of severe side effects. This study will evaluate etanercept's safety and effectiveness, and particularly its value in reducing the need for prednisone and preventing disease relapse. The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis, another inflammatory disease. The drug works by blocking the activity of TNF-a protein made by white blood cells that is involved in the inflammatory process. Since prednisone also affects inflammatory proteins and lowers TNF production, the use of etanercept may reduce the need for prednisone in patients with Wegener's granulomatosis, and thus the risk of its side effects. Patients between 10 and 70 years of age with Wegener's granulomatosis who have never taken prednisone, methotrexate or cyclophosphamide, or have taken these drugs for less than 3 weeks may be eligible for this study. Participants will have a medical history review and physical examination, including laboratory studies. If medically indicated, X-rays, consultations and biopsies (surgical removal of a small tissue sample) of affected organs will also be done. All patients will begin treatment with prednisone, methotrexate and etanercept. Those who improve on this regimen will stop prednisone gradually over 3 months. Those who achieve disease remission at the end of another 3 months will be randomly assigned to either continue taking etanercept and methotrexate for another 12 months or to stop etanercept and continue only methotrexate for the next 12 months (after which methotrexate will gradually be stopped). Patients who are not in remission by the 6-month point will continue taking etanercept until they go into remission, when they will be assigned to stop or not stop etanercept, as described above. Patients who do not achieve remission within 12 months of beginning treatment will be taken off the study. Patients who have a disease relapse while on the study will likely be switched to treatment with prednisone and either methotrexate or cyclophosphamide. Patients randomized to stop etanercept and who have a relapse within a year of stopping the drug may be offered re-treatment on this protocol, but with continuing etanercept for a full year after remission. Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months and every 1 to 3 months after that. Patients whose disease is in remission and who stop all medications will be followed every 3 to 6 months for 2 years. Follow-up evaluations include a physical examination, blood draws and, if medically indicated, X-rays. The total study duration is 60 to 70 months.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ENBREL

Condition Name

Condition Name for ENBREL
Intervention Trials
Rheumatoid Arthritis 48
Psoriasis 26
Ankylosing Spondylitis 12
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Condition MeSH

Condition MeSH for ENBREL
Intervention Trials
Arthritis 72
Arthritis, Rheumatoid 64
Psoriasis 37
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Clinical Trial Locations for ENBREL

Trials by Country

Trials by Country for ENBREL
Location Trials
United States 425
Canada 72
United Kingdom 37
Germany 28
Spain 26
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Trials by US State

Trials by US State for ENBREL
Location Trials
California 28
Texas 23
New York 22
Maryland 22
Florida 20
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Clinical Trial Progress for ENBREL

Clinical Trial Phase

Clinical Trial Phase for ENBREL
Clinical Trial Phase Trials
Phase 4 56
Phase 3 31
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for ENBREL
Clinical Trial Phase Trials
Completed 109
Recruiting 21
Terminated 13
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Clinical Trial Sponsors for ENBREL

Sponsor Name

Sponsor Name for ENBREL
Sponsor Trials
Amgen 44
Pfizer 30
Wyeth is now a wholly owned subsidiary of Pfizer 15
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Sponsor Type

Sponsor Type for ENBREL
Sponsor Trials
Industry 139
Other 117
NIH 21
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