Sarilumab for Juvenile Idiopathic Arthritis
Recruiting in Palo Alto (17 mi)
+87 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Sanofi
Must not be taking: Anti-IL-6, Biologics, JAK inhibitors, others
Disqualifiers: Severe systemic symptoms, Lung disease, others
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing sarilumab, a medication that reduces inflammation, in children and teenagers with a specific type of arthritis called sJIA. The medication works by blocking a protein that causes inflammation.
Will I have to stop taking my current medications?
The trial requires that certain medications be stable for a period before starting, like NSAIDs for 2 weeks and non-biologic DMARDs for 6 weeks. Some treatments, like biologics for sJIA, must be stopped for a specific time before the trial. Check with the trial team for details on your specific medications.
What data supports the effectiveness of the drug Sarilumab (Kevzara) for treating Juvenile Idiopathic Arthritis?
While there is no direct data on Sarilumab for Juvenile Idiopathic Arthritis, similar drugs like tocilizumab, which also targets inflammation, have shown effectiveness in treating polyarticular-course juvenile idiopathic arthritis, suggesting potential benefits of Sarilumab for similar conditions.
12345Is Sarilumab safe for use in humans?
Sarilumab, also known as Kevzara, has been approved for treating rheumatoid arthritis in adults and is being studied for juvenile idiopathic arthritis. It has been shown to be generally safe, but like other similar treatments, it may cause side effects such as serious infections. Ongoing monitoring and data collection are important to ensure its safety in children.
678910How is the drug Sarilumab different from other treatments for juvenile idiopathic arthritis?
Sarilumab is unique because it targets the interleukin-6 receptor, which is a different mechanism compared to other treatments like adalimumab that target tumor necrosis factor. This different approach may offer an alternative for patients who do not respond well to other treatments.
1112131415Eligibility Criteria
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.Inclusion Criteria
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.
+2 more
Exclusion 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.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Core Treatment
Participants receive sarilumab by subcutaneous injection during the core treatment phase
12 weeks
Extension Treatment
Participants continue to receive sarilumab during the extension phase
144 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks
Participant Groups
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).
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.
Sarilumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Kevzara for:
- Rheumatoid arthritis
🇺🇸 Approved in United States as Kevzara for:
- Rheumatoid arthritis
- Polymyalgia rheumatica
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Investigational Site Number 1240110Calgary, Canada
Investigational Site Number : 1240112Montreal, Canada
Investigational Site Number : 1240110Calgary, Canada
Investigational Site Number :1240112Montreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial. [2019]Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial.
Efficacy of repeated intravenous infusions of an anti-tumor necrosis factor alpha monoclonal antibody, infliximab, in persistently active, refractory juvenile idiopathic arthritis: results of an open-label prospective study. [2015]To evaluate the efficacy and safety of a chimeric monoclonal anti-tumor necrosis factor alpha antibody (infliximab) with methotrexate (MTX) in juvenile idiopathic arthritis (JIA) with an active polyarticular course that is not responsive to MTX.
Current and future perspectives in the management of juvenile idiopathic arthritis. [2019]The treatment of juvenile idiopathic arthritis has improved tremendously in the past 20 years as a result of appropriate legislative initiatives, large international collaborative networks, and the availability of new potent medications. Despite these considerable advances, a sizable proportion of patients are still resistant to treatment. Further improvement will stem from a better definition of the disease entities under the broad term juvenile idiopathic arthritis (which includes all forms of arthritis with disease onset before the age of 16 years); the discovery of laboratory and imaging biomarkers that could help the tuning of therapy; smoother implementation of clinical trials; more standardised links between academia, regulatory authorities, and patient organisations for the planning of future trials; and the availability of new drugs that selectively target molecules or pathways involved in inflammation.
Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. [2022]To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).
Towards molecular-pathology informed clinical trials in childhood arthritis to achieve precision medicine in juvenile idiopathic arthritis. [2023]In childhood arthritis, collectively known as Juvenile idiopathic arthritis (JIA), the rapid rise of available licensed biological and targeted small molecule treatments in recent years has led to improved outcomes. However, real-world data from multiple countries and registries show that despite a large number of available drugs, many children and young people continue to suffer flares and experience significant periods of time with active disease for many years. More than 50% of young people with JIA require ongoing immune suppression well into adult life, and they may have to try multiple different treatments in that time. There are currently no validated tools with which to select specific treatments, nor biomarkers of response to assist in such choices, therefore, current management uses essentially a trial-and-error approach. A further consequence of recent progress is a reducing pool of available children or young people who are eligible for new trials. In this review we consider how progress towards a molecular based approach to defining treatment targets and informing trial design in JIA, combined with novel approaches to clinical trials, could provide strategies to maximise discovery and progress, in order to move towards precision medicine for children with arthritis.
Sarilumab: First Global Approval. [2018]Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan. Sarilumab is also under phase II investigation for the treatment of juvenile idiopathic arthritis. This article summarizes the milestones in the development of sarilumab leading to its first global approval for the treatment of rheumatoid arthritis.
What are the immunological consequences of long-term use of biological therapies for juvenile idiopathic arthritis? [2022]This review summarizes the immunological consequences of biological therapies used in juvenile idiopathic arthritis (JIA). For every frequently used biological agent the characteristics are clearly specified (molecular target, isotype, registered indication for JIA, route of administration, half-life, contraindication, very common side effects, expected time of response and average cost in the first year). The emphasis of this review is on the immunological side effects that have been encountered for every separate agent in JIA populations. For each agent these adverse events have been calculated as incidence per 100 patient-years for the following categories: serious infections, tuberculosis, malignancies, response to vaccination, new-onset autoimmune diseases and development of anti-drug antibodies. There are large differences in side effects between various agents and there is a clear need for an international and standardized collection of post-marketing surveillance data of biologicals in the vulnerable group of JIA patients. Such an international pharmacovigilance database, called Pharmachild, has now been started.
Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate. [2021]Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
Sarilumab reduces disease activity in rheumatoid arthritis patients with inadequate response to janus kinase inhibitors or tocilizumab in regular care in Germany. [2022]The aim was to evaluate the safety and effectiveness of sarilumab in RA patients after inadequate response (IR) to janus kinase inhibitors (JAKi) and tocilizumab.
Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. [2020]Safety and efficacy of mAbs blocking the IL-6 receptor have been established in RA. This is the first analysis examining safety and tolerability of sarilumab and tocilizumab administered as single or multiple doses in patients with RA within the same study.
Usefulness of adalimumab in the treatment of refractory uveitis associated with juvenile idiopathic arthritis. [2022]To assess the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA) and associated refractory uveitis.
Efficacy and safety of adalimumab as the first and second biologic agent in juvenile idiopathic arthritis: the German Biologics JIA Registry. [2016]To evaluate the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA).
Outcome of Juvenile Idiopathic Arthritis Associated Uveitis in Two Disease Subtypes. [2022]This study aims to evaluate the efficacy of adalimumab as a first line biologic agent in specific subtypes of juvenile idiopathic arthritis (JIA) patients with associated uveitis.
ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. [2019]To assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate response to topical steroids and methotrexate (MTX).
Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. [2022]Systemic-onset juvenile idiopathic arthritis does not always respond to available treatments, including antitumour necrosis factor agents. We investigated the efficacy and safety of tocilizumab, an anti-interleukin-6-receptor monoclonal antibody, in children with this disorder.