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

Last updated: February 4, 2025
Sponsor: Duke University
Overall Status: Completed

Phase

3

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Joint Injuries

Treatment

Usual Care

Abatacept Injection

Clinical Study ID

NCT03841357
Pro00100523
  • Ages 2-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study:

  1. Age ≥ 2 years old and ≤16.5 years old

  2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months

  3. Arthritis affecting ≤4 joints between disease onset and enrollment

  4. Enrollment in the CARRA Registry

  5. 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.

  6. 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.

  1. Systemic JIA as defined by 2004 ILAR criteria1

  2. Sacroiliitis (clinical or radiographic)

  3. Inflammatory bowel disease (IBD)

  4. History of psoriasis or currently active psoriasis

  5. History of uveitis or currently active uveitis

  6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication)

  7. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)

  8. History of active or chronic liver disease

  9. Chronic or acute renal disorder

  10. 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

  11. 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

  12. Participation in another concurrent clinical interventional study within 30 days of enrollment

  13. Known positive human immunodeficiency virus (HIV)

  14. Received a live virus vaccine within 1 month of the baseline visit

  15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB

  16. Pregnant, breast feeding, or planned breast feeding during the study duration

  17. Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months

  18. Active malignancy of any type or history of malignancy

  19. 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

  20. Primary language other than English or Spanish

  21. Positive for Hepatitis B surface antigen or core antibody

  22. <10 Kg in weight

  23. 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.

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase: 3
Study Start date:
October 29, 2019
Estimated Completion Date:
January 22, 2025

Study Description

Part I enrolled participants into a randomized open-label multicenter trial with a planned sample size of 306 JIA participants recruited from CARRA Registry sites. Participants were randomly allocated (1:1) to receive 24 weeks of abatacept plus usual care or usual care alone. Upon completion of 24 weeks of randomized treatment, each participant was to receive usual care and undergo follow-up for assessment of outcomes for an additional 12 months. Planned duration of the study for each participant was 18 months. Due to slow accrual and apparent loss of equipoise, enrollment into Part I has been discontinued 17February2022 As of October 29, 2021, 39 participants have been randomized in Part I. Part I participants will continue follow-up as planned.

Part II is a non-randomized continuation of LIMIT-JIA with planned enrollment of 89 to reach 80 evaluable participants receiving to the abatacept arm. Participants will now receive 24 doses of abatacept plus usual care. Upon completion of 24 doses of treatment, each participant will receive usual care and undergo follow-up for assessment of outcomes for an additional 6 months. Planned duration of the study for each participant is 12 months. Part II will assess the efficacy of abatacept in prevention of disease extension by comparison of outcomes between participants enrolled in the abatacept arm and 428 CARRA Registry patients who would have met major eligibility criteria for LIMIT-JIA.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of California at San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • The Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Shands at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa Hospitals of Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Minnesota; Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Children's Hospital at Montefiore/ Albert Einstein University Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • Hospital of Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Levine Children's Hospital/ Carolina Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke Children's Hospital and Health Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Wake Forest Baptist Hospital

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • MetroHealth System

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Monroe Carell Jr Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84158
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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