Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

All Drugs and Chemicals

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

Etanercept (Enbrel) 50mg twice weekly injections for 12 weeks

Placebo Injections twice weekly for 12 weeks

Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.

Placebo injections twice weekly for 12 weeks.

Placebo injections

Gerald D Weinstein, M.D.

The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).

This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with palmoplantar psoriasis (PPP). Subjects who meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at approximately the same time of day over the 12-week treatment period. The primary efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12 weeks, all patients (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.

Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet

Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe.

Amgen

University of California, Irvine

Professor and Chair of Dermatology

Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.

Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks

Subjects randomized placebo injection for 12 weeks. An additional follow-up visit was performed on week 28.

Subjects Receiving Placebo for 12 Weeks

Subjects randomized to use etanercept 50mg twice weekly for 12 weeks.

Subjects randomized to placebo injection twice weekly for 12 weeks.

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Steven Feldman, MD, PhD

Subjects randomized placebo injection for 12 weeks.

Subjects Receiving Placebo for the First 12 Weeks

The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.

Subjects were randomized to receive etanercept 50mg twice weekly injection for 12 weeks. Subjects were then treated for another 12 weeks with etanercept 50 mg twice weekly. An additional follow-up visit performed on week 28.

Subjects randomized to receive placebo injection twice weekly for 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50 mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.

Overall Study

Musculoskeletal Diseases

Immune System Diseases

Eye Diseases

Infections

Rare Diseases

Inflammation

Arthritis

Arthritis, Rheumatoid

Arthritis, Juvenile

Uveitis

Endophthalmitis

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Uveal Diseases

Immunomodulating Agents

Enbrel

This study will investigate the safety and effectiveness of the drug TNFR:Fc to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis. In other studies, TNFR:Fc significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis, and the Food and Drug Administration has approved the drug for that use. Because medicines for arthritis often help patients with eye inflammation, this study will examine whether TNFR:Fc can help patients with uveitis.

Patients with uveitis who are not responding well to standard treatment, such as steroids, and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study. Candidates will be screened with a medical history, physical examination, and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina), and front of the eye, including measurements of protein and inflammation. Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test and joint evaluation will also be done.

Study participants will be given a shot of TNFR:Fc twice a week for up to 12 months and may continue other medicines they may be taking, such as prednisone or methotrexate. They will have follow-up examinations at week two and months one, two, three and four. Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six, nine and 12, and one month after treatment ends. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine.

Current treatment modalities for uveitis associated with Juvenile Rheumatoid Arthritis (JRA) including corticosteroids and other immunosuppressive agents are associated with significant side effects. These treatments are not effective for all children. A soluble tumor necrosis factor receptor (TNFR:Fc) named Etanercept, may inhibit the inflammatory response of uveitis. This randomized double-masked phase I/II clinical trial will provide limited safety and efficacy information regarding the use of Etanercept for the treatment of uveitis associated with JRA. Fifteen patients will be randomized with a 2 to 1 randomization plan (10 to receive Etanercept, 5 to receive placebo) and followed for 6 months. After the 6 month visit, all patients will receive open label Etanercept for an additional 6 months. Patients will be switched to open label Etanercept, or withdrawn from study therapy prior to 6 months, if they a) experience a greater than 10 letter or greater drop in visual acuity due to inflammation, for patients using the ETDRS chart (a 2 line drop due to inflammation, for patients using the B-VAT method) or b) develop a sight-threatening inflammatory ophthalmic or joint lesion requiring immediate increase in systemic anti-inflammatory therapy or a periocular injection of corticosteriods or c) at 4 months, have greater than 1 plus anterior chamber cell grade in either eye and are receiving topical corticosteroids on a schedule of TID or more frequently. Investigators will remain masked to original treatment assignment unless warranted by clinical care considerations. Primary safety outcomes include the occurrence of any severe adverse event at least possibly related to study therapy, including a two step increase in anterior chamber cells, or the occurrence of serious infection or sepsis. Primary ophthalmic outcomes include measures of anterior chamber cells and a change in topical or systemic anti-inflammatory medications used to treat uveitis. Primary ophthalmic and JRA outcome analysis will be performed at 6 months, and again at 12 months. Patients unmasked or switched to open label Etanercept prior to month 6 or withdrawing from the study drug prior to month 12 will be considered failures.

TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

National Eye Institute (NEI)

Neoplasms

Blood and Lymph Conditions

Leukemia

Leukemia, Myelomonocytic, Juvenile

Neoplasms by Histologic Type

Hematologic Diseases

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Bone Marrow Diseases

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

0.8 mg/kg subcutaneously weekly for 90 days

0.8 mg/kg Subcutaneously Once A Week for 90 Days

Robert J. Wells, MD

Primary Objectives:

1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML.

1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) \[mutations in NF1, Ras, SHP2\] or levels of TNFa.

1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts.

1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.

Etanercept blocks a hormone called Tumor Necrosis Factor (TNF), which has been shown to play a role in helping the growth of leukemic cells in JMML.

Before participants can start treatment on this study, they will have what are called "screening tests". These tests will help the doctor decide if patients are eligible to take part in the study. You will have a complete medical history and physical exam. About two tablespoons of blood and urine will be collected for routine tests as well as to test for the liver and kidney function. You will have a bone marrow biopsy performed to monitor disease activity. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. You will have cells from inside of the mouth tested for genetic changes by swabbing the side of the cheeks.

If you are found to be eligible, etanercept will be given as an injection under the skin once a week for up to 90 days.

During the study, you will have weekly follow-up tests that will include physical exam and lab tests. About 2 tablespoons of blood will be collected each time. Urine will also be collected for testing at least every 3 weeks while on the study.

If the disease gets worse or intolerable side effects occur, you will be taken off study and alternative treatment options will be discussed.

This is an investigational study. The FDA has approved etanercept for use in adults and children with rheumatoid arthritis and juvenile rheumatoid arthritis. Its use in this study is experimental. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

Phase IIA Window Study of Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

Response is defined as a WBC \< 15,000 and platelets \> 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.

M.D. Anderson Cancer Center

Age Continuous

Early termination due to low accrual. Rare disease with less than 100 cases diagnosed per year.

Robert J. Wells, MD / Professor

No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.

Patient Response

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumor

Neuroepithelioma

open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks

Patients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter.

etanercept

Boni E Elewski, MD

In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.

Can We Miss Pigmented Lesions in Psoriasis Patients?

The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

University of Alabama at Birmingham

Principal Investigator

open label treatment per FDA approval for 24 weeks

Boni Elewski, MD

The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.

Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.

A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria

Nutritional and Metabolic Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

Neoplasms, Plasma Cell

Lymphoproliferative Disorders

Immunoproliferative Disorders

Paraproteinemias

AL Amyloidosis

Mohamad A Hussein, MD

John A Lust, MD, PhD

The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary systemic Amyloidosis.

The primary goal of this study is to evaluate the efficacy of Enbrel in patients with primary systemic amyloidosis using a one-stage, phase II study design with an interim analysis. This study will also assess survival and progression times, symptom relief, and toxicity associated with Enbrel in primary systemic amyloidosis patients. Two groups of patients with very different risk profiles can be identified with respect to this disease. Patients with symptomatic cardiac disease and/or at least two involved organs ar at high risk and historically have a median survival less than six months. Patients without these conditions have a significantly better prognosis. Both subgroups will be studied in the present study, and essentially two phase-II clinical trials, one for each subgroup, will be run in parallel.

Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis

The Cleveland Clinic

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Lung Injury

Bronchiolitis

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Premature Birth

Infant, Premature, Diseases

Infant, Newborn, Diseases

Bronchitis

Communicable Diseases

Respiratory Tract Infections

Bronchial Diseases

Lung Diseases, Obstructive

Thoracic Injuries

Pneumonia

Organizing Pneumonia

Graft vs Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Bronchiolitis Obliterans Organizing Pneumonia

Homologous Wasting Disease

Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Gregory A Yanik, MD

The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study

Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .

To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury \> 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.

University of Michigan Rogel Cancer Center

Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.

Etanercept for lung injury

Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet	NCT00585650	Psoriasis	Etanercept Placebo injecti...	18 Years - 70 Years	University of California, Irvine
TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis	NCT00001862	Juvenile Rheuma... Uveitis	Enbrel	-	National Institutes of Health Clinical Center (CC)
Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia	NCT00509600	Leukemia	Etanercept	6 Months - 18 Years	M.D. Anderson Cancer Center
Can We Miss Pigmented Lesions in Psoriasis Patients?	NCT01053819	Psoriasis Melanoma Non-melanoma Sk...	etanercept	19 Years -	University of Alabama at Birmingham
Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis	NCT00224393	Primary Systemi...	Enbrel	18 Years -	The Cleveland Clinic
Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis	NCT00224393	Primary Systemi...	Enbrel	18 Years -	The Cleveland Clinic
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant	NCT00141726	Lung Injury, Ac... Respiratory Dis... Bronchiolitis O...	Etanercept	6 Years -	University of Michigan Rogel Cancer Center
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet	NCT00585650	Psoriasis	Etanercept Placebo injecti...	18 Years - 70 Years	University of California, Irvine

Spots Global Cancer Trial Database for enbrel

Every month we try and update this database with for enbrel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for enbrel

Every month we try and update this database with for enbrel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for enbrel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.