CompletedPhase 3

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

United States121 participantsStarted 2019-10-29

Plain-language summary

This is a research study to test whether a once-weekly injection of abatacept will prevent the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication within 18 months of randomization in children with recent-onset limited JIA.

Who can participate

Age range2 Years – 16 Years

SexALL

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Inclusion criteria

✓. 1\. Systemic JIA as defined by 2004 ILAR criteria1
✓. Sacroiliitis (clinical or radiographic)
✓. Inflammatory bowel disease (IBD)
✓. History of psoriasis or currently active psoriasis
✓. History of uveitis or currently active uveitis
✓. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication)
✓. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone \[≤ 14 days\] is allowed)
✓. History of active or chronic liver disease

What they're measuring

Composite of All Primary Endpoints

Timeframe: From randomization to day 410

Number of Participants With Polyarthritis

Timeframe: From randomization to day 592

Number of Participants With Uveitis

Timeframe: From randomization to day 410

Number of Participants With Systemic Medications

Timeframe: From randomization day 410

Trial details

NCT IDNCT03841357

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-22

Results submitted2025-10-06

View on ClinicalTrials.gov More Juvenile Idiopathic Arthritis trials