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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.
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
Study 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 belowSelect...
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.
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
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 moreSide effects data
From 2016 Phase 3 trial • 243 Patients • NCT0229390233%
Nasopharyngitis
12%
Neutropenia
10%
Injection site erythema
10%
Upper respiratory tract infection
10%
Hepatic function abnormal
9%
Eczema
9%
Alanine aminotransferase increased
7%
Stomatitis
6%
Injection site pruritus
6%
Cystitis
5%
Periodontitis
5%
White blood cell count decreased
5%
Bronchitis
5%
Pharyngitis
5%
Hypertension
2%
Neutrophil count decreased
2%
Back pain
2%
Leukopenia
2%
Dental caries
2%
Diarrhoea
2%
Gastroenteritis
2%
Gingivitis
2%
Contusion
2%
Rheumatoid arthritis
2%
Ingrowing nail
1%
Herpes zoster
1%
Infective myositis
1%
Pneumocystis jirovecii pneumonia
1%
Sepsis
1%
Pharyngeal abscess
1%
Oral candidiasis
1%
Lumbar spinal stenosis
1%
Chronic gastritis
1%
Foot deformity
1%
Influenza
1%
Scoliosis
1%
Generalised erythema
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,408 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,775 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,227 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 4 weeks.I have severe heart problems because of my systemic juvenile idiopathic arthritis.I have a history of lung problems like interstitial lung disease.I haven't taken high doses of steroids (more than 60 mg/day) in the last 3 days.I haven't taken biologic treatment for sJIA within the required time before starting sarilumab.I haven't taken any experimental drugs within the last 8 weeks or 5 half-lives, whichever is longer.I have been diagnosed with systemic juvenile idiopathic arthritis.I have systemic JIA with fever and 2 active joints despite stable glucocorticoid treatment.My current arthritis treatment isn't working, and my doctor thinks I need a stronger medication.I haven't had severe symptoms or MAS in the last 6 months.My dose for non-biologic DMARD has been stable or not above recommended levels for less than 6 weeks.I have been taking NSAIDs with a stable dose for less than 2 weeks or outside the approved guidelines.I am pregnant or breastfeeding.I do not have a current or past infection, except for tuberculosis.My weight is either below 10 kg or above 60 kg for the initial study phase, and below 10 kg for later phases.I have 5 or more swollen, painful joints.I am between 1 and 17 years old.I have been treated with medications targeting IL-6 or IL-6R.I haven't had steroid injections in the last 4 weeks.I haven't taken Janus kinase inhibitors or growth hormone in the last 4 weeks.I do not have tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Sarilumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any previous investigations that have employed Sarilumab SAR153191 (REGN88)?
"At present, there are 7 clinical trials in progress with 2 of them being conducted at Phase 3. Omaha is one of the 465 locations worldwide that has active studies for Sarilumab SAR153191 (REGN88)."
Answered by AI
Who can partake in this medical research study?
"This trial is targeting 72 juvenile patients afflicted with arthritis between the ages of one and seventeen, regardless of gender. Furthermore, these participants must display a minimum 5 active joints at screening or two active joints while concurrently experiencing systemic JIA fever over 37.5 Celsius in three days prior to baseline assessment; glucocorticoids should be administered but kept on steady dosage for 3 consecutive days before testing commences. Lastly, those enrolled must have exhibited an insufficient response to current treatments and are thus considered candidates for biologic disease modifying anti-rheumatic drugs per physician's discretion."
Answered by AI
Are enrolments for this research project open at the moment?
"Affirmative, the information on clinicaltrials.gov reveals that this research is currently recruiting participants. This examination was initially published on August 9th 2018 and most recently updated on October 14th 2022. The study requires 72 patients to be recruited at 3 distinct centres of care."
Answered by AI
Is the enrollment criteria of this trial including persons over the age of 55?
"This trial is seeking out adolescents aged between 1 and 17. Consequently, there are 57 studies targeting this demographic while 319 focuses on those 65 and beyond."
Answered by AI
Is Sarilumab SAR153191 (REGN88) a secure treatment option for individuals?
"Our team assesses the safety of Sarilumab SAR153191 (REGN88) as a 2, given that no efficacy data exists but there is evidence for its relative protection."
Answered by AI
What is the participant count for this trial?
"Affirmative, the clinicaltrials.gov website advertises that this research is actively searching for participants. This trial was initially posted on August 9th 2018 and lastly modified on October 14th 2022 with the aim of enrolling a total of 72 subjects at three different study centres."
Answered by AI
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