Abatacept Injection for Juvenile Idiopathic Arthritis

(Limit-JIA Trial)

No longer recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a weekly injection of abatacept can prevent Juvenile Idiopathic Arthritis (JIA) from worsening. Researchers are comparing the effectiveness of abatacept combined with usual care (such as steroid joint injections and non-steroidal anti-inflammatory drugs) against usual care alone in preventing severe forms like polyarthritis (affecting five or more joints) or other complications. Children diagnosed with JIA in the last six months and who have arthritis in four or fewer joints might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial requires that you have not been treated with systemic medications for JIA before, and you cannot be on systemic glucocorticoids within 30 days of joining, except for a short course of oral prednisone (up to 14 days). If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that abatacept injection is likely to be safe for humans?

Research has shown that abatacept injections are generally safe for children with Juvenile Idiopathic Arthritis (JIA). Studies have found that using abatacept for up to 7 years did not cause any new safety concerns and helped control the disease. Other research found no serious infections linked to abatacept, and it effectively improved symptoms for many children. Overall, these findings suggest that abatacept is a safe option for managing JIA symptoms in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Juvenile Idiopathic Arthritis?

Researchers are excited about abatacept injections for juvenile idiopathic arthritis because they offer a unique approach by targeting a specific part of the immune system. Unlike standard treatments that often involve steroid injections and non-steroidal anti-inflammatory drugs (NSAIDs) to manage symptoms, abatacept works by interfering with T-cell activation, which plays a crucial role in the inflammation process of arthritis. This targeted mechanism may not only improve symptom management but also potentially alter the disease course, offering hope for more effective long-term outcomes. Additionally, abatacept is administered through weekly injections, which could provide a more consistent delivery method compared to some existing treatments.

What evidence suggests that abatacept injection could be an effective treatment for Juvenile Idiopathic Arthritis?

Research shows that abatacept can help manage Juvenile Idiopathic Arthritis (JIA). In this trial, some participants will receive abatacept as an injection alongside usual care, which includes steroid joint injections and non-steroidal anti-inflammatory drugs. Studies have found that abatacept injections help control the disease in children with JIA. This treatment is generally well-tolerated, with most children not experiencing new safety issues, and it can help the disease become inactive. For children with a type of JIA affecting many joints, abatacept has significantly improved symptoms. Many patients have shown symptom improvement levels of 30%, 50%, 70%, 90%, or even 100%. Overall, abatacept is a promising option for slowing the progression of JIA. ^{1 3 4 6 7}

Who Is on the Research Team?

Laura Schanberg, MD

Principal Investigator

Duke University

Eveline Wu, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5054936/

Long‐Term Safety, Efficacy, and Quality of Life in Patients With ... The aim of this study was to present the safety, efficacy, and patient‐reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03841357

Preventing Extension of Oligoarticular Juvenile Idiopathic ... 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 ...

3. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/full/10.1002/art.40466

Subcutaneous Abatacept in Patients With Polyarticular ... Other outcome measures included JIA-ACR 30, 50, 70, 90, 100, and inactive disease status, the median Juvenile Arthritis Disease Activity Score ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38243722/

Safety and effectiveness of abatacept in juvenile idiopathic ... Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity.

5. jrheum.org jrheum.org/content/early/2023/08/28/jrheum.2022-1320

Abatacept as Monotherapy and in Combination With ... Objective To describe the efficacy and safety data of children with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381685/

Safety and effectiveness of abatacept in juvenile idiopathic ... Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients ...

7. ped-rheum.biomedcentral.com ped-rheum.biomedcentral.com/articles/10.1186/s12969-025-01069-4

Safety and effectiveness of intravenous abatacept for ... Abatacept is effective in polyarticular-course JIA, particularly in RF-positive patients, and in restoring a child's growth.