Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (Limit-JIA)
Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Polyarthritis, abatacept, uveitis, prevention
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
- University of California at San Francisco Medical CenterRecruiting
- The Children's Hospital ColoradoRecruiting
- Shands at the University of FloridaRecruiting
- Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital
- University of Chicago
- Riley Hospital for Children at Indiana University HealthRecruiting
- University of Iowa Hospitals of ClinicsRecruiting
- University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research UnitRecruiting
- Boston Children's HospitalRecruiting
- University of Minnesota; Children's Hospital and Clinics of MinnesotaRecruiting
- Mayo Clinic
- Hackensack University Medical CenterRecruiting
- The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health
- Children's Hospital at Montefiore/ Albert Einstein University HospitalRecruiting
- Hospital of Special Surgery
- University of North CarolinaRecruiting
- Levine Children's Hospital/ Carolina Medical Center
- Duke Children's Hospital and Health Center
- Cincinnati Children's Hospital Medical CenterRecruiting
- MetroHealth SystemRecruiting
- Nationwide Children's HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Monroe Carell Jr Children's Hospital at VanderbiltRecruiting
- University of UtahRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Abatacept and Usual Care (Part I)
Active Comparator: Usual Care (Part I)
Abatacept and Usual Care (Part II)
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
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider
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