TerminatedPhase 3

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

Stopped: the study was terminated because of slow enrollment

19 participantsStarted 2001-06-04

Plain-language 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).

Who can participate

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 CRITERIA: * Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids * Pregnant or nursing female * Clinically significant abnormal laboratory test results for blood cells, liver or kidney 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

What they're measuring

Number of Participants in Part 2 With Disease Flare

Timeframe: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)

Trial details

NCT IDNCT00078806

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-05-06

Results submitted2019-06-26

View on ClinicalTrials.gov More Juvenile Rheumatoid Arthritis trials