Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Arthritis, Juvenile

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

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

Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.

Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to continue receiving etanercept twice weekly for up to 4 additional months.

Administered twice weekly by subcutaneous injection

Placebo

The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.

This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier.

Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903).

Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)

Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis

Disease flare was defined as a 30% or greater worsening in three of the six JRA Core Set Criteria and ≥ 30% improvement in one or less of the six JRA Core Set Criteria compared to day 90 and a minimum of two active joints (joints with swelling or limitation of movement plus pain and/or tenderness).

The JRA Core Set criteria consisted of:

* Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms);
* Patient/parent global assessment of overall well-being assesses on a VAS from 0 (asymptomatic) to 10 (severe symptoms);
* Number of active joints;
* Number of joints with limitation of motion (LOM) and with pain, tenderness, or both;
* Childhood Health Assessment Questionnaire (CHAQ) disability domain;
* Erythrocyte sedimentation rate (ESR).

The time from day 90 to flare. Participants who withdrew without flare were censored at the time of withdrawal.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1.

Part 1: Etanercept 0.4 mg/kg

n Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.

Part 2: Placebo

In Part 2 participants were randomized to continue receiving 0.4 mg/kg etanercept twice weekly for up to 4 additional months.

Part 2: Etanercept 0.4 mg/kg

In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.

Total

Part 1

Part 2

Part 1 and Part 2 baseline data are reported separately since Part 2 participants represent a subset of Part 1.

Age, Continuous

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Onset type is determined by manifestations during the first 6 months of disease.

Pauciarticular JRA: Arthritis in 4 or fewer joints during the first 6 months of disease.

Polyarticular JRA: Arthritis in 5 or more joints during the first 6 months of disease.

Systemic onset JRA: Arthritis with persistent intermittent fever with or without rheumatoid rash or other organ involvement.

Type of Onset of Juvenile Rheumatoid Arthritis (JRA)

Baseline data are included for all enrolled participants in part 1 (69) and all participants who randomized in part 2 (51).

Study Director

Percentage of Participants With Disease Flare in Part 2

Time to Flare in Part 2

Noninfectious adverse events

Injection site reactions

Infections

Serious adverse events

Deaths

All participants who received at least one dose of study drug

Number of Participants With Adverse Events

Eye Diseases

Rare Diseases

Inflammation

Uveitis

Endophthalmitis

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)

Wounds and Injuries

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Burns

Anemia, Sickle Cell

Anemia

Chronic Pain

Pain

Neurologic Manifestations

Sickle Cell Anemia

Chronic Graft Versus Host Disease

Central Nervous System Depressants

Adjuvants, Anesthesia

Analgesics, Opioid

Oxymorphone

Narcotics

Anesthetics

oxymorphone IR

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID

Endo Pharmaceuticals

Sr. Director CR & D

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)	NCT03780959	Juvenile Rheuma...	Etanercept Placebo	4 Years - 18 Years	Amgen
Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)	NCT03780959	Juvenile Rheuma...	Etanercept Placebo	4 Years - 18 Years	Amgen
TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis	NCT00001862	Juvenile Rheuma... Uveitis	Enbrel	-	National Institutes of Health Clinical Center (CC)
Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)	NCT03780959	Juvenile Rheuma...	Etanercept Placebo	4 Years - 18 Years	Amgen
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects	NCT01206907	Chronic Pain	oxymorphone IR	2 Years - 6 Years	Endo Pharmaceuticals

Spots Global Cancer Trial Database for juvenile rheumatoid arthritis