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

• Status: Completed
• Trial end date: 1998-07-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Diagnosis of JRA by the American College of Rheumatology (ACR) criteria.

• Disease course must be polyarticular with disease duration long enough to have been given an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose methotrexate at a dose of at least 10 mg/m²/week

• Continuing active disease, defined as ≥ 5 swollen joints and ≥ 3 joints with limitation of motion accompanied by pain, tenderness or warmth.

• Disease refractory to methotrexate or intolerant of methotrexate.

• Have not received disease-modifying anti-rheumatic drugs (DMARDs) within 28 days prior to enrollment.

• Have not received methotrexate within 14 days prior to dosing of study drug.

Exclusion Criteria:

• Pregnant or nursing female

• Functional class IV by ACR criteria

• Unable to meet concomitant medication restrictions

• Intraarticular corticosteroid injection within 4 weeks prior to enrollment

• Clinically significant deviations from normal, defined as:

• thrombocytopenia; platelet count < 100,000/cmm

• leukopenia; total white cell count < 4000 cells/cmm

• neutropenia; neutrophils < 1000 cells/cmm

• hepatic transaminase levels > two times the upper limit of normal (ULN)

• serum bilirubin > 2 times ULN

• creatinine clearance < 90 mL/min/1.73 m² body surface area (BSA) and/or a glomerular filtration rate (GFR) < 90 mL/min/1.73 m² BSA.

• known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity, or hepatitis C positivity.

• anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies or anti-cardiolipin antibodies present.

• Previously received antibody to TNF, antibody to cluster of differentiation (CD)4, or diphtheria interleukin (IL)-2-fusion protein (DAB-IL-2)

• Participated in a study of an investigational drug or biologic requiring informed consent within 3 months prior to study entry.

• Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or make the patient unable to cooperate with the protocol.

• History of or current psychiatric illness that would interfere with ability to comply with protocol requirements or informed consent.

• History or drug or alcohol abuse that would interfere with ability to comply with protocol requirements