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New hope for kids with rare arthritis: drug dose study underway

NCT ID NCT02991469

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for children and teens aged 1 to 17 with systemic juvenile idiopathic arthritis (sJIA), a condition that causes joint swelling and fever. Researchers are testing different doses of the drug sarilumab to find the best amount that works and is safe. The study involves 51 participants and will monitor how the drug moves through the body and its effects over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, ≥6 to ≤17 years for Russia) at the time of the screening visit. * Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria OR According to 2024 EULAR/PReS recommendation at Screening. * Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator's judgment. Exclusion criteria: * Body weight \<10 kg or \>60 kg for patients enrolled in the ascending dose cohorts, then body weight \<10 kg for patients subsequently enrolled at the selected dose. * Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening. * History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis. * If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors \[COX-2\]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label. * If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling. * If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline. * Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline. * Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab. * Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements). * Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements). * Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer. * Exclusion related to tuberculosis. * Exclusion criteria related to past or current infection other than tuberculosis. * Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment. * Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product. * Laboratory abnormalities at the screening visit (identified by the central laboratory). * Severe cardiac disease due to sJIA. * Pregnant or breast-feeding female adolescent patients. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis systemic-onset juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile idiopathic arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number : 0320004

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Investigational Site Number : 0320005

    RECRUITING

    Buenos Aires, 1023, Argentina

  • Investigational Site Number : 1240110

    RECRUITING

    Calgary, Alberta, T3B 6A9, Canada

  • Investigational Site Number : 2460040

    RECRUITING

    Helsinki, 00029, Finland

  • Investigational Site Number : 2500040

    RECRUITING

    Paris, 75015, France

  • Investigational Site Number : 2500041

    RECRUITING

    Bron, 69500, France

  • Investigational Site Number : 2500042

    RECRUITING

    Montpellier, 34295, France

  • Investigational Site Number : 2760060

    RECRUITING

    Sankt Augustin, 53757, Germany

  • Investigational Site Number : 2760062

    RECRUITING

    Hamburg, 22081, Germany

  • Investigational Site Number : 2760063

    COMPLETED

    Sendenhorst, 48324, Germany

  • Investigational Site Number : 2760064

    RECRUITING

    Berlin, 13125, Germany

  • Investigational Site Number : 2760065

    RECRUITING

    Berlin, 13353, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Athens, 115 27, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Thessaloniki, 546 42, Greece

  • Investigational Site Number : 3720001

    RECRUITING

    Crumlin, Dublin, D12 N512, Ireland

  • Investigational Site Number : 3800051

    RECRUITING

    Genoa, Genova, 16147, Italy

  • Investigational Site Number : 3800052

    RECRUITING

    Rome, Roma, 00165, Italy

  • Investigational Site Number : 3800054

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 6200003

    RECRUITING

    Lisbon, 1150-199, Portugal

  • Investigational Site Number : 6430001

    COMPLETED

    Moscow, 115522, Russia

  • Investigational Site Number : 6430062

    COMPLETED

    Moscow, 117997, Russia

  • Investigational Site Number : 6430063

    COMPLETED

    Moscow, 119991, Russia

  • Investigational Site Number : 6430065

    COMPLETED

    Ufa, 450083, Russia

  • Investigational Site Number : 7240050

    RECRUITING

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Investigational Site Number : 7240051

    RECRUITING

    Valencia, 46026, Spain

  • Investigational Site Number : 7240053

    RECRUITING

    Madrid, 28009, Spain

  • Investigational Site Number : 7240054

    RECRUITING

    Málaga, 29010, Spain

  • Investigational Site Number : 7240055

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240056

    RECRUITING

    Madrid, 28010, Spain

  • Investigational Site Number : 8260031

    COMPLETED

    London, London, City of, WC1N 3JH, United Kingdom

  • Investigational Site Number : 8260033

    COMPLETED

    Liverpool, L12 2AP, United Kingdom

  • Investigational Site Number : 8260034

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

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