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.
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 was discontinued. Part I participants continued 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 CARRA Registry patients who would have met major eligibility criteria for LIMIT-JIA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Supplied as a weekly injection via a pre-filled syringe
Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
University of California at San Francisco Medical Center
San Francisco, California, United States
Composite of All Primary Endpoints
Any of the following from randomization to day 410: polyarthritis \[\>=5 cumulative active joint count\], uveitis, initiation of systemic glucocorticoids (IV or PO), DMARDs or biologics.
Time frame: From randomization to day 410
Number of Participants With Polyarthritis
Polyarthritis is defined as \>=5 cumulative active joint count.
Time frame: From randomization to day 592
Number of Participants With Uveitis
Time frame: From randomization to day 410
Number of Participants With Systemic Medications
Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.
Time frame: From randomization day 410
Number of Participants With Clinically Inactive Disease or Remission
Clinical Inactive disease at any visit is a composite outcome consisting of all of: No active joints (Current Active Joint Count=0), No uveitis (Uveitis=No or not reported), Normal ESR (if obtained) (N/D or ESR≤ ULN or unrelated to JIA if \>ULN), Normal CRP (if obtained) (N/D or CRP≤ ULN or unrelated to JIA if \>ULN), AM stiffness duration=None or ≤ 15 minutes, Physician Global score=0.
Time frame: From baseline up to 12 months
Number of Participants With Disease Extension
Disease extension defined as development of polyarthritis or uveitis.
Time frame: From baseline up to 12 months
Number of New Active Joints Per Participant
Total number of joints that were not active prior to or at baseline, and became active after randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Children's Hospital Colorado
Aurora, Colorado, United States
Shands at the University of Florida
Gainesville, Florida, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospitals of Clinics
Iowa City, Iowa, United States
University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota; Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
...and 9 more locations
Time frame: From baseline up to 12 months
Number of Intra-articular Glucocorticoid Joint Injections Per Participant
Intra-articular glucocorticoid joint injections are reported in the CARRA Registry CRF at each Limit-JIA or CARRA Registry visit.
Time frame: From baseline up to 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS scores are T-scores and have a mean of 50 and standard deviation of 10.
Time frame: 6 months and 12 months
Juvenile Arthritis Disease Activity Score (JADAS)
The JADAS (Juvenile Arthritis Disease Activity Score) is a composite tool used to assess disease activity in children with Juvenile Idiopathic Arthritis (JIA). The total score ranges from 0 to 40, where a higher score indicates a more severe level of disease activity.
Time frame: 6 months and 12 months