Status:
COMPLETED
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Lead Sponsor:
Duke University
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-16 years
Phase:
PHASE3
Brief 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 o...
Detailed 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...
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:
- 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.
Exclusion
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2025
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03841357
Start Date
October 29 2019
End Date
January 22 2025
Last Update
February 5 2025
Active Locations (19)
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1
University of California at San Francisco Medical Center
San Francisco, California, United States, 94143
2
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Shands at the University of Florida
Gainesville, Florida, United States, 32610
4
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202