Open-label extension with filgotinib for juvenile idiopathic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension enrolls children aged 8 to <18 years with polyarticular or systemic juvenile idiopathic arthritis who completed a parent filgotinib study and demonstrated clinical benefit. Participants continue on filgotinib and are followed over time with regular clinic visits to monitor long-term safety, tolerability, and sustained control of signs and symptoms. The protocol includes safety monitoring by clinical assessment and laboratory testing and excludes patients who developed conditions during the parent study that would preclude safe continuation, those with active significant infection, or pregnancy. Data collected will document adverse events, laboratory abnormalities, and clinical measures of disease activity to characterize extended treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols
* Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol evaluations
* Female or male subject 8 to \<18 years of age, on the date of signing the informed consent and assent (per local regulation) form
* Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the clinical study protocol.

Exclusion Criteria:

* Development of any condition during the parent study that would preclude safe continuation
* Pregnancy
* Active infection that is clinically significant, as per Investigator's judgement
* Subject with known hypersensitivity to the components of potential study therapy
* Subjects with any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements

Where it's running

• Bicetre Hospital
  Le Kremlin-Bicêtre, France Recruiting
• Hamburger Zentrum für Kinder- und Jugendrheumatologie
  Hamburg, Germany Recruiting
• Asklepios Klinik Sankt Augustin GmbH
  Sankt Augustin, Germany Not yet recruiting
• Great Ormond Street Hospital for Children
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Catherine Vincent
• Email: medicalinfo@alfasigma.com
• Phone: 00800 7878 1345

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting the course of early-onset juvenile idiopathic arthritis using a multidimensional model

  Researchers are testing a comprehensive model to predict how early-onset JIA will progress in affected children and how a small control group with iridocyclitis compares.

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• Understanding subtypes of chronic musculoskeletal pain in youth

  This observational study tests whether distinct brain and immune profiles can explain chronic musculoskeletal pain in teens and young adults to guide more precise treatments.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07602595

• Filgotinib for children with polyarticular juvenile idiopathic arthritis

  This study tests whether and how filgotinib works and is tolerated in children and adolescents with active polyarticular JIA over about 18 weeks.

  Recruiting at 14 sites Phase 3 Alfasigma S.p.A. · Leuven and 13 other locations · NCT07554495

• Structured or video-game–based core stabilization for children with juvenile idiopathic arthritis

  This study will try whether a regular structured core exercise program or a fun exergaming-based core program helps children aged 8–13 with juvenile idiopathic arthritis improve strength, reduce pain, and move better.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Buyukcekmece · NCT07234747

• Tofacitinib in Juvenile Idiopathic Arthritis

  This study looks at real-world use of tofacitinib to see if it helps control Juvenile Idiopathic Arthritis in kids over about 12 months.

  Recruiting at 7 sites Consorci Sanitari de l'Alt Penedès i Garraf · A Coruña, A Coruña and 6 other locations · NCT07211932

• Parents' pain catastrophizing in children with juvenile idiopathic arthritis

  See if parents' worrying and negative thoughts about their child's pain are linked to treatment adherence and biopsychosocial outcomes in children with juvenile idiopathic arthritis.

  Recruiting Hacettepe University · Çankaya, Ankara · NCT07185750

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.