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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 18 months
Awards & highlights

Limit-JIA Trial 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.Check my eligibility
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.See study design
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.

Limit-JIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My arthritis affects 4 or fewer joints since it started.
Select...
I am between 2 and 16.5 years old.
Select...
My arthritis affects 4 or fewer joints since it started.

Limit-JIA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Joint Count by Physician Exam (Part I)
Change in Joint Count by Physician Exam (Part II)
Uveitis
+1 more
Secondary outcome measures
Change in anxiety by PROMIS (Part I)
Change in anxiety by PROMIS (Part II)
Change in depression by PROMIS (Part I)
+13 more

Limit-JIA 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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,101 Total Patients Enrolled
Stephen Balevic, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
230 Total Patients Enrolled
Laura Schanberg, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
29,587 Total Patients Enrolled

Media Library

Abatacept Injection (Biological DMARD) Clinical Trial Eligibility Overview. Trial Name: NCT03841357 — Phase 3
Juvenile Idiopathic Arthritis Research Study Groups: Abatacept and Usual Care (Part II), Active Comparator: Usual Care (Part I), Abatacept and Usual Care (Part I)
Juvenile Idiopathic Arthritis Clinical Trial 2023: Abatacept Injection Highlights & Side Effects. Trial Name: NCT03841357 — Phase 3
Abatacept Injection (Biological DMARD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03841357 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Abatacept Injection met the FDA's standards for approval?

"Abatacept Injection's safety is supported by multiple rounds of clinical data, giving it a score of 3."

Answered by AI

Are there still positions available for volunteers in this experiment?

"Yes, this trial is still open and recruiting patients. 28 different hospitals or clinics are participating in the study, which was first posted on October 29th, 2019. The most recent update to the trial's information was on August 16th, 2022 and the goal is to have 130 people enrolled by the end of recruitment."

Answered by AI

Are there other instances where Abatacept Injection has been studied?

"Abatacept Injection was first researched in 2007 at University of Nebraska Medical Center. As of now, there are 453 completed studies and 36 ongoing clinical trials. A majority of these active investigations are taking place in Minneapolis, Minnesota."

Answered by AI

What are some common indications for Abatacept Injection?

"Abatacept Injection is frequently used to mitigate the effects of rheumatoid arthritis. However, it can also be given to patients suffering from psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

May I be a subject in this clinical trial?

"Eligible participants for this arthritis clinical trial must be between 2 and 16 years old, have arthritis affecting 4 or fewer joints, a history of psoriasis or currently active psoriasis, and weigh 50 kg or more (only at Canadian sites). To enroll in the Limit-JIA study, patients must sign a consent form."

Answered by AI

How many individuals are being observed in this clinical trial?

"That is correct. The clinical trial in question, which was first posted on October 29th 2019, is still recruiting patients across 28 sites. So far, 130 people have enrolled in the study."

Answered by AI

Could you inform me how many hospitals are administering this trial at the present time?

"Patients are being enrolled at various hospitals and clinics including University of Minnesota; Children's Hospital and Clinics of Minnesota in Minneapolis, Minnesota, The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health in West Orange, Washington, Seattle Children's Hospital in Seattle, Illinois , and 28 other locations."

Answered by AI

Does this clinical trial have an age limit? If so, what is it?

"Eligible applicants for this trial must be between 2 and 16 years old. Out of the total428 clinical trials, 67 focus on pediatrics while 361 are for geriatrics."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
65+
What site did they apply to?
Hackensack University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Jan 2025