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Biological DMARD

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

Phase 3

Waitlist Available

Led By Stephen Balevic, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arthritis affecting ≤4 joints between disease onset and enrollment

Age ≥ 2 years old and ≤16.5 years old

Must not have

Primary language other than English or Spanish

Inflammatory bowel disease (IBD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 18 months

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test whether a weekly injection of abatacept can help prevent Juvenile Idiopathic Arthritis from progressing to a more severe form.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Abatacept may cause side effects such as infection risk increase due to immune system suppression, allergic reactions at the injection site, headache, nausea, and possibly increased risk of developing certain types of cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My arthritis affects 4 or fewer joints since it started.

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I am between 2 and 16.5 years old.

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My arthritis affects 4 or fewer joints since it started.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My primary language is not English or Spanish.

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I have been diagnosed with inflammatory bowel disease.

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I have a kidney condition.

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I have a history of liver disease.

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My liver and kidney tests are within normal limits.

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I have had or currently have uveitis.

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

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I have inflammation in my lower back joints.

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I have or currently suffer from psoriasis.

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

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I have been diagnosed with systemic juvenile idiopathic arthritis.

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I have or had cancer.

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I weigh less than 10 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Joint Count by Physician Exam (Part I)

Change in Joint Count by Physician Exam (Part II)

Uveitis

+1 more

Secondary study objectives

Change in anxiety by PROMIS (Part I)

Change in anxiety by PROMIS (Part II)

Change in depression by PROMIS (Part I)

+11 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

FDA approved

0 / 16Eligibility criteria met