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CompletedPhase 3

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

Key facts

Who runs it
Duke University
Where
Aurora, Boston, Chapel Hill, Cincinnati, Cleveland, Columbus, Gainesville, Hackensack, Indianapolis, Iowa City, Louisville, Minneapolis, Nashville, Philadelphia, Rochester, Salt Lake City, San Francisco, Seattle, and The Bronx, United StatesSee the 19 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
121 people enrolled
Started
29 Oct 2019
Ended
22 Jan 2025
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Abatacept Injection
  • Usual Care
Record updated
23 January 2026

Who can take part

Age
2 years to 16 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 30 criteriaShow less

Other criteria

  • To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study:
  • Age ≥ 2 years old and ≤16.5 years old
  • Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months
  • Arthritis affecting ≤4 joints between disease onset and enrollment
  • Enrollment in the CARRA Registry
  • Participants of childbearing potential must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 66 days after taking the last dose of study drug
  • Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent to participate in the Limit-JIA study; The presence of any of the following will exclude a study participant from inclusion in the study:
  • 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
  • Chronic or acute renal disorder
  • AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5 mg/dL or any other laboratory abnormality considered by the examining physician to be clinically significant within 2 months of the enrollment visit
  • Presence of any medical or psychological condition or laboratory result which would make the participant, in the opinion of the investigator, unsuitable for the study
  • Participation in another concurrent clinical interventional study within 30 days of enrollment
  • Known positive human immunodeficiency virus (HIV)
  • Received a live virus vaccine within 1 month of the baseline visit
  • Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB
  • Pregnant, breast feeding, or planned breast feeding during the study duration
  • Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months
  • Active malignancy of any type or history of malignancy
  • Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
  • Primary language other than English or Spanish
  • Positive for Hepatitis B surface antigen or core antibody
  • <10 Kg in weight
  • If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19 exposure at screening, it is recommended that the site follow CDC guidance regarding testing and quarantine requirements. The subject can be re-screened when there is no longer concern for active infection. A subject with a positive COVID -19 test may be re-screened

Where in United States

  • The Children's Hospital ColoradoAurora, United States
  • Boston Children's HospitalBoston, United States
  • University of North CarolinaChapel Hill, United States
  • Cincinnati Children's Hospital Medical CenterCincinnati, United States
  • MetroHealth SystemCleveland, United States
  • Nationwide Children's HospitalColumbus, United States
  • Shands at the University of FloridaGainesville, United States
  • Hackensack University Medical CenterHackensack, United States
  • Riley Hospital for Children at Indiana University HealthIndianapolis, United States
  • University of Iowa Hospitals of ClinicsIowa City, United States
  • University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research UnitLouisville, United States
  • University of Minnesota; Children's Hospital and Clinics of MinnesotaMinneapolis, United States
  • Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United States
  • Children's Hospital of PhiladelphiaPhiladelphia, United States
  • Mayo ClinicRochester, United States
  • University of UtahSalt Lake City, United States
  • University of California at San Francisco Medical CenterSan Francisco, United States
  • Seattle Children's HospitalSeattle, United States
  • Children's Hospital at Montefiore/ Albert Einstein University HospitalThe Bronx, United States

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Abatacept and Usual Care (Part I)Treatment being tested

    Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider.

    Treatment: Abatacept Injection and Usual Care

  • Active Comparator: Usual Care (Part I)Existing treatment, for comparison

    Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.

    Treatment: Usual Care

  • Abatacept and Usual Care (Part II)Treatment being tested

    Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider.

    Treatment: Abatacept Injection and Usual Care

  • Active Comparator: Usual Care (Part II)Existing treatment, for comparison

    Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.

    Treatment: Usual Care

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Record updated
23 January 2026