Phase
Condition
Connective Tissue Diseases
Collagen Vascular Diseases
Joint Injuries
Treatment
Usual Care
Abatacept Injection
Clinical Study ID
Ages 2-16 All Genders
Study Summary
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.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
University of California at San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
The Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Shands at the University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Iowa Hospitals of Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit
Louisville, Kentucky 40202
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
University of Minnesota; Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota 55454
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health
West Orange, New Jersey 07052
United StatesSite Not Available
Children's Hospital at Montefiore/ Albert Einstein University Hospital
Bronx, New York 10461
United StatesSite Not Available
Hospital of Special Surgery
New York, New York 10021
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Levine Children's Hospital/ Carolina Medical Center
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke Children's Hospital and Health Center
Durham, North Carolina 27705
United StatesSite Not Available
Wake Forest Baptist Hospital
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
MetroHealth System
Cleveland, Ohio 44109
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84158
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available

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