Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

Last updated: August 23, 2019
Sponsor: Amgen
Overall Status: Terminated

Phase

3

Condition

Rheumatoid Arthritis

Rheumatoid Arthritis (Pediatric)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00078806
20021631
  • Ages 2-18
  • All Genders

Study Summary

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • 2 - 18 years of age

  • SOJRA for at least 3 months, with stable systemic features

  • If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable

  • Must take prednisone at a stable dose

Exclusion

EXCLUSION CRITERIA:

  • Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroidsor intra-articular steroids

  • Pregnant or nursing female

  • Clinically significant abnormal laboratory test results for blood cells, liver orkidney function, or serology

  • Previous receipt of any tumor necrosis factor (TNF) inhibitor

  • Live virus vaccine within 12 weeks of study entry

  • Participation in another study requiring informed consent within 12 weeks of entry

  • Diabetes that requires insulin treatment

  • Infection, chronic, recurrent, or currently active

  • Any serious medical or psychiatric condition or history of alcohol or drug abuse

Study Design

Total Participants: 19
Study Start date:
June 04, 2001
Estimated Completion Date:
May 06, 2004

Study Description

Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.