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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2025 by Duke University
Sponsor
Duke University
Information Provided by (Responsible Party)
Duke University
Clinicaltrials.gov Identifier
NCT03841357
Other Study ID Numbers:
Pro00100523
First Submitted
January 29, 2019
First Posted
February 14, 2019
Results First Posted
October 5, 2025
Last Update Posted
January 22, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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 (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.

Condition or DiseaseIntervention/Treatment
Juvenile Idiopathic Arthritis
Drug: Abatacept InjectionOther: Usual CareDrug: Abatacept InjectionOther: Usual Care

Study Design

Study TypeInterventional
Actual Enrollment121 participants
Design AllocationNon-Randomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
Study Start DateOctober 28, 2019
Actual Primary Completion DateJanuary 21, 2025
Actual Study Completion DateJanuary 21, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Abatacept and Usual Care (Part I)
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.
Drug: Abatacept Injection
Supplied as a weekly injection via a pre-filled syringe
Active Comparator: Usual Care (Part I)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Other: Usual Care
Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
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.
Drug: Abatacept Injection
Supplied as a weekly injection via a pre-filled syringe
Active Comparator: Usual Care (Part II)
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Other: Usual Care
Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. Number of Participants With Polyarthritis
    Polyarthritis is defined as \>=5 cumulative active joint count.
  3. Number of Participants With Uveitis
  4. Number of Participants With Systemic Medications
    Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.
Secondary Outcome Measures
  1. 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.
  2. Number of Participants With Disease Extension
    Disease extension defined as development of polyarthritis or uveitis.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study: 1. Age ≥ 2 years old and ≤16.5 years old 2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months 3. Arthritis affecting ≤4 joints between disease onset and enrollment 4. Enrollment in the CARRA Registry 5. 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. 6. 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. 1\. Systemic JIA as defined by 2004 ILAR criteria1 2. Sacroiliitis (clinical or radiographic) 3. Inflammatory bowel disease (IBD) 4. History of psoriasis or currently active psoriasis 5. History of uveitis or currently active uveitis 6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication) 7. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone \[≤ 14 days\] is allowed) 8. History of active or chronic liver disease 9. Chronic or acute renal disorder 10. 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 11. 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 12. Participation in another concurrent clinical interventional study within 30 days of enrollment 13. Known positive human immunodeficiency virus (HIV) 14. Received a live virus vaccine within 1 month of the baseline visit 15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB 16. Pregnant, breast feeding, or planned breast feeding during the study duration 17. Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months 18. Active malignancy of any type or history of malignancy 19. 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 20. Primary language other than English or Spanish 21. Positive for Hepatitis B surface antigen or core antibody 22. \<10 Kg in weight 23. 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 Criteria
To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study: 1. Age ≥ 2 years old and ≤16.5 years old 2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months 3. Arthritis affecting ≤4 joints between disease onset and enrollment 4. Enrollment in the CARRA Registry 5. 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. 6. 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. 1\. Systemic JIA as defined by 2004 ILAR criteria1 2. Sacroiliitis (clinical or radiographic) 3. Inflammatory bowel disease (IBD) 4. History of psoriasis or currently active psoriasis 5. History of uveitis or currently active uveitis 6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication) 7. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone \[≤ 14 days\] is allowed) 8. History of active or chronic liver disease 9. Chronic or acute renal disorder 10. 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 11. 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 12. Participation in another concurrent clinical interventional study within 30 days of enrollment 13. Known positive human immunodeficiency virus (HIV) 14. Received a live virus vaccine within 1 month of the baseline visit 15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB 16. Pregnant, breast feeding, or planned breast feeding during the study duration 17. Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months 18. Active malignancy of any type or history of malignancy 19. 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 20. Primary language other than English or Spanish 21. Positive for Hepatitis B surface antigen or core antibody 22. \<10 Kg in weight 23. 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.

Contacts and Locations

Sponsors and CollaboratorsDuke University
Locations
University of California at San Francisco Medical Center | San Francisco California, United States, 94143The Children's Hospital Colorado | Aurora Colorado, United States, 80045Shands at the University of Florida | Gainesville Florida, United States, 32610Riley Hospital for Children at Indiana University Health | Indianapolis Indiana, United States, 46202University of Iowa Hospitals of Clinics | Iowa City Iowa, United States, 52242University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit | Louisville Kentucky, United States, 40202Boston Children's Hospital | Boston Massachusetts, United States, 02115University of Minnesota; Children's Hospital and Clinics of Minnesota | Minneapolis Minnesota, United States, 55454Mayo Clinic | Rochester Minnesota, United States, 55905Hackensack University Medical Center | Hackensack New Jersey, United States, 07601Children's Hospital at Montefiore/ Albert Einstein University Hospital | The Bronx New York, United States, 10461University of North Carolina | Chapel Hill North Carolina, United States, 27514Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45229MetroHealth System | Cleveland Ohio, United States, 44109Nationwide Children's Hospital | Columbus Ohio, United States, 43205Children's Hospital of Philadelphia | Philadelphia Pennsylvania, United States, 19104Monroe Carell Jr Children's Hospital at Vanderbilt | Nashville Tennessee, United States, 37232University of Utah | Salt Lake City Utah, United States, 84158Seattle Children's Hospital | Seattle Washington, United States, 98105
Investigators
Principal Investigator: Laura Schanberg, MD, Duke UniversityPrincipal Investigator: Eveline Wu, MD, University of North Carolina, Chapel Hill
Study Documents (Full Text)
Documents provided by Duke University: Study Protocol and Statistical Analysis Plan  February 16, 2022