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Juvenile Idiopathic ArthritisPhase 3Limit-JIANCT03841357

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

A Phase 3 study testing Abatacept Injection in people with Juvenile Idiopathic Arthritis, run by Duke University at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 2 to 16 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Abatacept Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
19 sitesUnited States
Study dates
29 Oct 2019to 22 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites
  • The Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • MetroHealth System

    Cleveland, Ohio, 44109

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Shands at the University of Florida

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals of Clinics

    Iowa City, Iowa, 52242

  • University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit

    Louisville, Kentucky, 40202

  • University of Minnesota; Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55454

  • Monroe Carell Jr Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84158

  • University of California at San Francisco Medical Center

    San Francisco, California, 94143

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Children's Hospital at Montefiore/ Albert Einstein University Hospital

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

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.

Read the detailed 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.

Being tested
Abatacept Injection, Usual Care
Keywords
Polyarthritis, abatacept, uveitis, prevention
Medical subject headings
Arthritis, Juvenile, Arthritis, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abatacept InjectionDrug

    Also called Orencia

    Supplied as a weekly injection via a pre-filled syringe

  • Usual CareOther

    Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs

Study groups in NCT03841357
Study groupRoleWhat they receive
Abatacept and Usual Care (Part I)ExperimentalWeekly 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.
Receives: Drug: Abatacept Injection; Other: Usual Care
Active Comparator: Usual Care (Part I)Active comparatorUsual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Receives: Other: Usual Care
Abatacept and Usual Care (Part II)ExperimentalWeekly 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.
Receives: Drug: Abatacept Injection; Other: Usual Care
Active Comparator: Usual Care (Part II)Active comparatorUsual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization to day 410

  2. Number of Participants With Polyarthritis

    Polyarthritis is defined as >=5 cumulative active joint count.

    Measured: From randomization to day 592

  3. Number of Participants With Uveitis

    Measured: From randomization to day 410

  4. Number of Participants With Systemic Medications

    Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.

    Measured: From randomization day 410

Secondary outcomes (12)
  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.

    Measured: From baseline up to 12 months

  2. Number of Participants With Disease Extension

    Disease extension defined as development of polyarthritis or uveitis.

    Measured: From baseline up to 12 months

  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.

    Measured: From baseline up to 12 months

  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.

    Measured: From baseline up to 12 months

  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.

    Measured: 6 months and 12 months

  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.

    Measured: 6 months and 12 months

  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.

    Measured: 6 months and 12 months

  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.

    Measured: 6 months and 12 months

  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.

    Measured: 6 months

  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.

    Measured: 6 months

  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.

    Measured: 6 months and 12 months

  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.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start29 Oct 2019
  3. Primary completion22 Jan 2025
  4. Study completion22 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841357
Sponsor's protocol ID
Pro00100523
Acronym
Limit-JIA
Status last verified
Jan 2026
First submitted
30 Jan 2019
Last updated
23 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept Injection in people with Juvenile Idiopathic Arthritis, run by Duke University at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of All Primary Endpoints (time frame: From randomization to day 410). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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