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Phase 3 N=783 Treatment

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

Juvenile Idiopathic Arthritis

Enrolled (actual)
783
Serious AEs
0.5%
Results posted
Jan 2026
Primary outcome: Primary: Composite of All Primary Endpoints — 13; 14; 41; 245 Participants — p=0.7357

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Abatacept Injection (Drug); Usual Care (Other)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Composite of All Primary Endpoints
13; 14; 41; 245; 54; 259 0.7357
PRIMARY
Number of Participants With Polyarthritis
8; 6; 14; 49; 22; 55 0.507
PRIMARY
Number of Participants With Uveitis
1; 0; 4; 31; 5; 31
PRIMARY
Number of Participants With Systemic Medications
11; 14; 41; 229; 52; 243 0.327
SECONDARY
Number of Participants With Clinically Inactive Disease or Remission
8; 3; 36; 246; 48; 264
SECONDARY
Number of Participants With Disease Extension
7; 6; 11; 67; 18; 73
SECONDARY
Number of New Active Joints Per Participant
1.40; 1.50; 0.70; 0.40; 0.80; 0.50
SECONDARY
Number of Intra-articular Glucocorticoid Joint Injections Per Participant
0.90; 1.80; 0.40; 0.40; 0.50; 0.40
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference
49.00; 50.90; 46.90; 49.60 0.005 sig
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue
39.60; 43.50; 39.80; 47.10 0.174
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function
44.30; 42.20; 44.10; 42.30 0.012 sig
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility
51.00; 49.20; 50.30; 50.70 <0.001 sig
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety
40.60; 43.60
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression
40.00; 43.30
SECONDARY
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
42.50; 42.10; 43.00; 42.70 0.002 sig
SECONDARY
Juvenile Arthritis Disease Activity Score (JADAS)
2.60; 3.00; 2.50; 2.60 <0.001 sig

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03841357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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