Abatacept Injection for Juvenile Idiopathic Arthritis

(Limit-JIA Trial)

Recruiting at 20 trial locations

Overseen By Alex Fist, MPH

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Duke University

Must not be taking: DMARDs, Biologics, Glucocorticoids, others

Disqualifiers: Systemic JIA, Psoriasis, Uveitis, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

121 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Laura Schanberg, MD

Principal Investigator

Duke University

Eveline Wu, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for children aged 2 to 16.5 with recent-onset Juvenile Idiopathic Arthritis affecting up to 4 joints and not yet severe. They must be enrolled in the CARRA Registry, agree to birth control if applicable, and weigh over 50 kg in Canada. Exclusions include a history of psoriasis or uveitis, certain infections or treatments, other clinical study participation within 30 days, and various medical conditions.

Inclusion Criteria

My arthritis affects 4 or fewer joints since it started.

I am between 2 and 16.5 years old.

My arthritis affects 4 or fewer joints since it started.

Exclusion Criteria

Known positive human immunodeficiency virus (HIV)

Participation in another concurrent clinical interventional study within 30 days of enrollment

Pregnant, breast feeding, or planned breast feeding during the study duration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Part I)

Participants receive 24 weeks of abatacept plus usual care or usual care alone

24 weeks

Follow-up (Part I)

Participants undergo follow-up for assessment of outcomes after treatment

12 months

Treatment (Part II)

Participants receive 24 doses of abatacept plus usual care

24 weeks

Follow-up (Part II)

Participants undergo follow-up for assessment of outcomes after treatment

6 months

Treatment Details

Interventions

• Abatacept Injection

Trial Overview The study tests if abatacept injections plus usual care can prevent Juvenile Idiopathic Arthritis from worsening compared to usual care alone over a period of six months. The goal is to stop arthritis from spreading beyond four joints or leading to other complications within an eighteen-month follow-up.

Participant Groups

Group I: Abatacept and Usual Care (Part II) Experimental Treatment 2 Interventions

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

Group II: Abatacept and Usual Care (Part I) Experimental Treatment 2 Interventions

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

Group III: Active Comparator: Usual Care (Part I) Active Control 1 Intervention

Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+