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

A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

Keywords

Juvenile Idiopathic Arthritis Polyarthritis abatacept uveitis prevention Arthritis Arthritis, Juvenile 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 randomization
  4. Clinically active arthritis of at least 1 joint at the time of enrollment ¹
  5. Enrollment in the CARRA Registry
  6. 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.
  7. 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
  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
  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 randomization 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 randomization
  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

Locations

  • University of California at San Francisco Medical Center
    San Francisco California 94143 United States
  • Seattle Children's Hospital
    Seattle Washington 98105 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT03841357
Phase
Phase 3
Study Type
Interventional
Last Updated