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

Last updated: June 10, 2019
Sponsor: Amgen
Overall Status: Completed

Phase

2/3

Condition

Rheumatoid Arthritis (Pediatric)

Rheumatoid Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT03780959
20021616
016.0016
  • Ages 4-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 beengiven an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dosemethotrexate at a dose of at least 10 mg/m²/week

  • Continuing active disease, defined as ≥ 5 swollen joints and ≥ 3 joints withlimitation 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 priorto enrollment.

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

Exclusion

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 aglomerular 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-cardiolipinantibodies present.

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

  • Participated in a study of an investigational drug or biologic requiring informedconsent 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 unableto cooperate with the protocol.

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

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

Study Design

Total Participants: 69
Study Start date:
May 01, 1997
Estimated Completion Date:
July 08, 1998

Study Description

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).