Summary

Eligibility
for people ages 2-16 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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)

Details

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.

Keywords

Juvenile Idiopathic Arthritis, Polyarthritis, abatacept, uveitis, prevention, Arthritis, Juvenile Arthritis, Abatacept Injection

Eligibility

For people ages 2-16

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. Systemic JIA as defined by 2004 ILAR criteria1
  1. Sacroiliitis (clinical or radiographic)
  2. Inflammatory bowel disease (IBD)
  3. History of psoriasis or currently active psoriasis
  4. History of uveitis or currently active uveitis
  5. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication)
  6. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)
  7. History of active or chronic liver disease
  8. Chronic or acute renal disorder
  9. . 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
  10. . 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
  11. . Participation in another concurrent clinical interventional study within 30 days of enrollment
  12. . Known positive human immunodeficiency virus (HIV)
  13. . Received a live virus vaccine within 1 month of the baseline visit
  14. . Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB
  15. . Pregnant, breast feeding, or planned breast feeding during the study duration
  16. . Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months
  17. . Active malignancy of any type or history of malignancy
  18. . 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
  19. . Primary language other than English or Spanish
  20. . Positive for Hepatitis B surface antigen or core antibody
  21. . <10 Kg in weight
  22. . 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.

Locations

  • University of California at San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT03841357
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated