Abatacept for Juvenile Idiopathic Arthritis

Not currently recruiting at 167 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Bristol-Myers Squibb

Must be taking: Abatacept

Disqualifiers: Pregnancy, Chronic infection, others

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of Abatacept (Orencia) for treating juvenile idiopathic arthritis (JIA), with a focus on serious infections, autoimmune issues, and potential cancers. The primary goal is to understand the long-term effects of this medication. Children and teens with any type of JIA who are already using Abatacept may be suitable for this study, particularly if they experience ongoing symptoms that affect their daily life. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since participants must already be receiving Abatacept, it seems likely that you can continue with your current treatment.

What is the safety track record for Abatacept?

Research shows that abatacept is generally safe and well-tolerated by patients. Studies have found that the likelihood of unwanted effects in people taking abatacept is similar to those taking a placebo (a harmless pill with no effect). Serious reactions, such as infections or certain types of cancer, can occur but are rare.

The FDA has approved abatacept for other conditions, indicating thorough study. It has a well-known safety record, and experts understand its effects well. While some risks exist, they are uncommon, and abatacept is considered safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Juvenile Idiopathic Arthritis, which often include NSAIDs, corticosteroids, and methotrexate, Abatacept is unique because it targets the immune system differently. It works by interfering with T-cell activation, which is a key player in the autoimmune process, thus helping to reduce inflammation and joint damage. Researchers are excited about Abatacept because it offers a targeted approach that could potentially have fewer side effects and improve long-term outcomes for patients.

What evidence suggests that Abatacept might be an effective treatment for juvenile idiopathic arthritis?

Research shows that Abatacept helps treat juvenile idiopathic arthritis (JIA) by calming the immune system to reduce swelling. In studies with individuals who have rheumatoid arthritis, a similar condition, more patients experienced remission, meaning their symptoms improved significantly, when using Abatacept. Specifically, the number of patients in remission increased from 46.1% in the first year to 55.2% in the second year. Abatacept demonstrated lasting effectiveness over time. Additionally, many patients who initially had high disease activity saw improvement, with 56.3% reaching low disease activity within a year of starting Abatacept. This evidence supports Abatacept as a promising treatment for JIA. ^{6 7 8 9 10}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Inclusion Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Diagnosis of JIA (any subtype)

Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Abatacept for the treatment of juvenile idiopathic arthritis

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on serious infections, autoimmune disorders, and malignancies

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Abatacept

Abatacept is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in United States as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in Canada as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Approved in Japan as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1.

orenciahcp.com

orenciahcp.com/efficacy-data.html

Efficacy Data - ORENCIA® (abatacept)

In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3383476/

The Efficacy and Safety of Abatacept in Rheumatoid Arthritis

Remission rate increased in patients treated also in year 2 from 46.1% at year 1 to 55.2% of patients at the end of year 2 [Westhovens et al. 2009f].

3.

news.bms.com

news.bms.com/news/details/2020/New-Data-Reinforce-Improved-and-Durable-Clinical-Responses-of-Orencia-in-Moderate-to-Severe-Early-Rheumatoid-Arthritis-Patients-with-Autoantibodies-Linked-to-More-Severe-Disease/default.aspx

New Data Reinforce Improved and Durable Clinical ...

Findings from open-label switch period of Early AMPLE study show that high efficacy responses observed at week 24 with Orencia were sustained through week 48.

4.

jheor.org

jheor.org/article/23684-persistence-with-early-line-abatacept-versus-tumor-necrosis-factor-inhibitors-for-rheumatoid-arthritis-complicated-by-poor-prognostic-factors

Persistence with Early-Line Abatacept versus Tumor ...

Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi ...

5.

becarispublishing.com

becarispublishing.com/doi/10.57264/cer-2023-0144

Real-world clinical outcomes and rationale for initiating ...

Of 279 patients not in CDAI low disease activity (LDA) or remission at baseline, 24.7% of patients achieved it within 6 months, 56.3% within 12 ...

6.

orenciahcp.com

orenciahcp.com/safety-data.html

Safety Data | ORENCIA® (abatacept)

The most serious adverse reactions associated with ORENCIA therapy were serious infections and malignancies.

7.

imgcdn.mckesson.com

imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9BRMY_ORENCIA_SUBCUTANEOUS_INJECTION.pdf

Material Safety Data Sheet

Hygiene. Wash hands and face before breaks and immediately after handling the product. Page 5. ORENCIA® (abatacept). Subcutaneous Injection, 125 mg/ml.

8.

fda.gov

fda.gov/media/142069/download

Orencia Safety and Utilization Review

The PK data supported the approval of SC abatacept for JIA. The safety analysis from this study did not identify any new safety signals. The ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6858048/

Safety of Abatacept Versus Placebo in Rheumatoid Arthritis

Clinical trials have also shown that abatacept is safe and well tolerated, with similar rates of adverse events (AEs) compared with placebo, demonstrating a ...

10.

orencia.com

orencia.com/about-orencia

ORENCIA® Side Effects & Rheumatoid Arthritis (RA) ...

ORENCIA has a well-established safety profile. This chart shows side effects reported by at least 3% of people, out of a total of 1955 who received ORENCIA and ...