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

NCT03841357 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: Pro00100523
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Polyarthritis; abatacept; uveitis; prevention

Outcome Measures

Primary Outcomes (4)

• 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.

  From randomization to day 410

• Number of Participants With Polyarthritis

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

  From randomization to day 592

• Number of Participants With Uveitis

  From randomization to day 410

• Number of Participants With Systemic Medications

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

  From randomization day 410

Secondary Outcomes (12)

• Number of Participants With Clinically Inactive Disease or Remission

  From baseline up to 12 months

• Number of Participants With Disease Extension

  From baseline up to 12 months

• Number of New Active Joints Per Participant

  From baseline up to 12 months

• Number of Intra-articular Glucocorticoid Joint Injections Per Participant

  From baseline up to 12 months

• PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference

  6 months and 12 months

Other Outcomes (1)

• Elapsed Time From Randomization to Primary Endpoint

  From randomization up to 12 months

Study Arms (4)

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.

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.

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.

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.

Other: Usual Care

Interventions

Abatacept Injection DRUG

Supplied as a weekly injection via a pre-filled syringe

Also known as: Orencia

Abatacept and Usual Care (Part I); Abatacept and Usual Care (Part II)

Usual Care OTHER

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 I); Abatacept and Usual Care (Part II); Active Comparator: Usual Care (Part I); Active Comparator: Usual Care (Part II)

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead

Study Sites (19)

University of California at San Francisco Medical Center

San Francisco, California, 94143, United States

Location

The Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals of Clinics

Iowa City, Iowa, 52242, United States

Location

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

Louisville, Kentucky, 40202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

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

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Children's Hospital at Montefiore/ Albert Einstein University Hospital

The Bronx, New York, 10461, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84158, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis; Uveitis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Laura Schanberg, M.D.
• Organization: Duke University

laura.schanberg@duke.edu

919-684-6575

Study Officials

• Laura Schanberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Eveline Wu, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: October 29, 2019
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)