What side effects are associated with this type of intervention?

Common treatments for Juvenile Idiopathic Arthritis (JIA), particularly biologic agents like Interleukin-6 Receptor Antagonists (e.g., Sarilumab), can have side effects such as increased risk of infections, injection site reactions, gastrointestinal symptoms, and liver enzyme abnormalities. Long-term use of these treatments may also be associated with an increased risk of malignancies and other immune-related conditions.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Juvenile Idiopathic Arthritis (JIA). Tocilizumab, another IL-6 receptor antagonist, is approved for systemic and polyarticular JIA. Additionally, other biologics such as etanercept (a TNF inhibitor), adalimumab (another TNF inhibitor), and abatacept (a T-cell co-stimulation modulator) are also approved for various forms of JIA. These treatments aim to reduce inflammation and prevent joint damage in children and adolescents with JIA.

What other types of research exist?

Promising novel alternatives to Sarilumab for Juvenile Idiopathic Arthritis patients include Tofacitinib, a Janus kinase (JAK) inhibitor, which has shown effectiveness in refractory cases of systemic JIA. Additionally, biologics such as Ustekinumab, which targets interleukin-12 and interleukin-23, and Vedolizumab, which targets integrin α4β7, are being explored for their potential benefits in pediatric inflammatory conditions and may offer new therapeutic options.

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Monoclonal Antibodies

Sarilumab for Juvenile Idiopathic Arthritis

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria with the following features:

- 2 active joints at screening with systemic JIA fever >37.5 0C in the 3 days preceding baseline or for at least 3 out of any 7 consecutive days during screening despite glucocorticoids at a dose stable for at least 3 days.

Must not have

History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.

If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up core treatment phase: up to week 12. extension phase: at weeks 24, 48, and every 24 weeks up to week 156

Awards & highlights

Summary

This trial is testing a new drug, sarilumab, for kids with sJIA to see what dose and regimen is best. They'll also look at how well it works and how safe it is.

Who is the study for?

This trial is for children and adolescents aged 1-17 with Systemic Juvenile Idiopathic Arthritis (sJIA) who haven't responded well to current treatments. They should not have used certain arthritis drugs recently, can't be on high doses of steroids, or have had live vaccines in the last month. Participants must weigh between 10 kg and 60 kg for initial dose groups.Check my eligibility

What is being tested?

The study tests Sarilumab's effects, dosage, and safety in young patients with sJIA. It aims to find the right dose for effective treatment by observing how the drug behaves in their bodies (pharmacokinetics) and its impact on the disease (pharmacodynamics).See study design

What are the potential side effects?

Sarilumab may cause allergic reactions, increased risk of infections due to immune system suppression, changes in blood test results indicating liver or blood cell issues, injection site reactions like redness or pain, and potentially other side effects common to biologic DMARDs.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with systemic juvenile idiopathic arthritis.

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I have systemic JIA with fever and 2 active joints despite stable glucocorticoid treatment.

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I have 5 or more swollen, painful joints.

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I am between 1 and 17 years old.

Exclusion Criteria

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

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I have a history of lung problems like interstitial lung disease.

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I haven't taken high doses of steroids (more than 60 mg/day) in the last 3 days.

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I haven't taken any experimental drugs within the last 8 weeks or 5 half-lives, whichever is longer.

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I have severe heart problems because of my systemic juvenile idiopathic arthritis.

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I am pregnant or breastfeeding.

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My weight is either below 10 kg or above 60 kg for the initial study phase, and below 10 kg for later phases.

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I have been treated with medications targeting IL-6 or IL-6R.

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I haven't had steroid injections in the last 4 weeks.

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I do not have tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ core treatment phase: up to week 12. extension phase: at weeks 24, 48, and every 24 weeks up to week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~core treatment phase: up to week 12. extension phase: at weeks 24, 48, and every 24 weeks up to week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and core treatment phase: up to week 12. extension phase: at weeks 24, 48, and every 24 weeks up to week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)

Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)

Assessment of PK parameter: maximum serum concentration observed (Cmax)

Secondary outcome measures

Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index

Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)

Change from baseline in JIA ACR Component: Number of joints with active arthritis

+13 more

Side effects data

From 2016 Phase 3 trial • 243 Patients • NCT02293902

33%

Nasopharyngitis

12%

Neutropenia

10%

Injection site erythema

10%

Upper respiratory tract infection

10%

Hepatic function abnormal

Eczema

Alanine aminotransferase increased

Stomatitis

Injection site pruritus

Cystitis

Periodontitis

White blood cell count decreased

Bronchitis

Pharyngitis

Hypertension

Neutrophil count decreased

Back pain

Leukopenia

Dental caries

Diarrhoea

Gastroenteritis

Gingivitis

Contusion

Rheumatoid arthritis

Ingrowing nail

Herpes zoster

Infective myositis

Pneumocystis jirovecii pneumonia

Sepsis

Pharyngeal abscess

Oral candidiasis

Lumbar spinal stenosis

Chronic gastritis

Foot deformity

Influenza

Scoliosis

Generalised erythema

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sarilumab 150 mg/150 mg

Sarilumab 200 mg/200 mg

Placebo/Sarilumab 150 mg

Placebo/Sarilumab 200 mg

Sarilumab Rescue

Trial Design

1Treatment groups

Experimental Treatment

Group I: SarilumabExperimental Treatment1 Intervention

Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sarilumab SAR153191 (REGN88)

2014

Completed Phase 3

~250

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Juvenile Idiopathic Arthritis (JIA) target the inflammatory pathways that drive the disease. Sarilumab, an Interleukin-6 (IL-6) receptor antagonist, works by blocking IL-6, a cytokine involved in inflammation and joint destruction. This helps reduce disease activity and prevent joint damage. Glucocorticoids, such as prednisone, suppress the overall immune response, providing rapid relief from inflammation but with potential long-term side effects. Methotrexate, a disease-modifying antirheumatic drug (DMARD), inhibits folate metabolism, reducing the proliferation of immune cells that cause inflammation. These treatments are crucial for JIA patients as they help manage symptoms, prevent joint damage, and improve quality of life.