Abatacept Injection for Juvenile Idiopathic Arthritis (Limit-JIA Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen ByStephen Balevic, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Duke University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

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.

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

My primary language is not English or Spanish.

I have been diagnosed with inflammatory bowel disease.

I have a kidney condition.

I have a history of liver disease.

My liver and kidney tests are within normal limits.

I have had or currently have uveitis.

I plan to switch to a new rheumatologist not in this study within a year.

I have inflammation in my lower back joints.

I have or currently suffer from psoriasis.

I have not had a live virus vaccine in the last month.

I have been diagnosed with systemic juvenile idiopathic arthritis.

I have or had cancer.

I weigh less than 10 kilograms.

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Abatacept and Usual Care (Part II)Experimental Treatment2 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 Treatment2 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 Control1 Intervention

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