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.
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:
- 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.
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
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.
- Conditions
- Juvenile Idiopathic Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| Abatacept and Usual Care (Part I) | Experimental | 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. Receives: Drug: Abatacept Injection; Other: Usual Care |
| Active Comparator: Usual Care (Part I) | Active comparator | Usual 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) | Experimental | 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. Receives: Drug: Abatacept Injection; Other: Usual Care |
| Active Comparator: Usual Care (Part II) | Active comparator | Usual 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.
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
Number of Participants With Polyarthritis
Polyarthritis is defined as >=5 cumulative active joint count.
Measured: From randomization to day 592
Number of Participants With Uveitis
Measured: From randomization to day 410
Number of Participants With Systemic Medications
Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.
Measured: From randomization day 410
Secondary outcomes (12)
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
Number of Participants With Disease Extension
Disease extension defined as development of polyarthritis or uveitis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted15 Feb 2019
- Study start29 Oct 2019
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Schanberg, MD, Principal investigator, Duke UniversityEveline Wu, MD, Principal investigator, University of North Carolina, Chapel Hill
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03841357
- Acronym / sponsor ID
- Limit-JIA / Pro00100523
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Polyarthritis, abatacept, uveitis, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abatacept and Usual Care (Part I) | Experimental | Drug: Abatacept Injection, Other: Usual CareWeekly 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. |
| Active Comparator: Usual Care (Part I) | Active comparator | Other: Usual CareUsual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider. |
| Abatacept and Usual Care (Part II) | Experimental | Drug: Abatacept Injection, Other: Usual CareWeekly 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. |
| Active Comparator: Usual Care (Part II) | Active comparator | Other: Usual CareUsual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept InjectionAlso: OrenciaSupplied as a weekly injection via a pre-filled syringe | Drug | Abatacept and Usual Care (Part I), Abatacept and Usual Care (Part II) |
| Usual CareUsual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs | Other | Abatacept and Usual Care (Part I), Abatacept and Usual Care (Part II), Active Comparator: Usual Care (Part I), Active Comparator: Usual Care (Part II) |
Primary outcome
Composite of All Primary Endpoints
Time frame: From randomization to day 410
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.
Number of Participants With Polyarthritis
Time frame: From randomization to day 592
Polyarthritis is defined as >=5 cumulative active joint count.
Number of Participants With Uveitis
Time frame: From randomization to day 410
Number of Participants With Systemic Medications
Time frame: From randomization day 410
Systemic glucocorticoids, Disease-Modifying Antirheumatic Drugs (DMARDs) or biologics.
12 secondary outcomes
Number of Participants With Clinically Inactive Disease or Remission
Time frame: From baseline up to 12 months
Number of Participants With Disease Extension
Time frame: From baseline up to 12 months
Number of New Active Joints Per Participant
Time frame: From baseline up to 12 months
Number of Intra-articular Glucocorticoid Joint Injections Per Participant
Time frame: From baseline up to 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Fatigue
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Upper Extremity Function
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Mobility
Time frame: 6 months and 12 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety
Time frame: 6 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression
Time frame: 6 months
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
Time frame: 6 months and 12 months
Juvenile Arthritis Disease Activity Score (JADAS)
Time frame: 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Schanberg, MD principal investigator
Duke University
Eveline Wu, MD principal investigator
University of North Carolina, Chapel Hill
19 sites in 1 country: see every site and its status.
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.