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 range

2 Years – 18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

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