A study to evaluate the safety and effectiveness of filgotinib in children and adolescents aged 8 to 17 years with polyarticular juvenile idiopathic arthritis

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What is this study about?

This study focuses on polyarticular-course juvenile idiopathic arthritis, a type of chronic joint inflammation that affects multiple joints in children and adolescents. The research aims to evaluate the safety and effectiveness of the drug filgotinib, which is also referred to by the code name GLPG0634. This medication is administered as an oral use treatment in the form of film-coated tablets.

The study will monitor how the body processes the medication, a process known as pharmacokinetics. It will also look at how well the drug works to reduce symptoms and whether it causes any side effects. During the course of the study, participants will be observed over several weeks to track changes in their condition and any potential reactions to the treatment.

Who Can Join the Study?

  • The person participating or their parent/guardian must agree to follow all the study rules and sign the informed consent form, which is a document that explains everything about the study before it begins.
  • The participant must be between 8 and 17 years old at the time they sign the study documents.
  • The person must have a specific type of juvenile idiopathic arthritis, which is a type of long-term joint inflammation that starts in childhood, and their symptoms must be moderate to severe.
  • The disease must not be well-managed with their current treatment, specifically in categories such as oligoarthritis (affecting a few joints), polyarthritis (affecting many joints), psoriatic arthritis (joint inflammation related to a skin condition), or enthesitis-related arthritis (inflammation where tendons or ligaments meet bone).
  • The participant must have either not responded well to or could not tolerate at least one type of medicine used for this condition for at least 3 months. This includes csDMARDs (standard medicines that help slow down the disease), bDMARDS (advanced medicines that target specific parts of the immune system), or non-steroidal anti-inflammatory drugs (medicines used to reduce pain and swelling).
  • Females who are able to become pregnant and are sexually active must agree to use contraception, which are methods used to prevent pregnancy, as explained in the study rules.

Who Cannot Join the Study?

  • People who weigh less than 15 kg (about 33 pounds).
  • People with oligoarthritis, which is a type of arthritis that affects 4 or fewer joints.
  • People with undifferentiated arthritis, which means the type of arthritis cannot be clearly categorized into a specific group.
  • People who have had anterior uveitis, which is inflammation inside the front part of the eye, that was active or not controlled within the last 12 weeks.
  • People with systemic JIA, a severe form of juvenile arthritis that affects the whole body and often includes fever and rashes.
  • People with any other rheumatic disease (conditions affecting joints and muscles), inflammatory disease (conditions involving swelling), or immunologic disease (conditions where the immune system is not working correctly). This includes inflammatory bowel disease (problems with the digestive tract), hypogammaglobulinemia (low levels of certain proteins in the blood that help fight infection), or systemic lupus erythematosus (an autoimmune disease where the body attacks its own tissues).
  • People who have an active infection.
  • People who have a history of a complicated herpes zoster infection (commonly known as shingles) that spread to multiple areas of the skin, affected the eyes, or affected the central nervous system (the brain and spinal cord).
  • People who have any other health condition or laboratory abnormalities (unusual results from blood or urine tests) that the doctor believes might prevent them from finishing the study or following the rules of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Katholieke Universiteit te Leuven Leuven Belgium
Centrum Medyczne “Hipokrates” s.c. Elżbieta i Grzegorz Grześk Bydgoszcz Poland

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev Sofia Bulgaria
Nosokomeio Paidon I Agia Sofia Athens Greece
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Hippokration Hospital Athens Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum St. Georg gGmbH Leipzig Germany
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Hospital Universitario De Cruces Barakaldo Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
University Of Pecs Pecs Hungary
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Hopital Beaujon Clichy France
University Of Szeged Szeged Hungary
Medical Center for Specialized Care for Cardiovascular Diseases EAD Sofia Bulgaria
Czlnpoggj Upukiwopqvghwg Szjizgeit Woluwe-Saint-Lambert Belgium
Hlcnrxia Hy Ntor Barcelona Spain
Muglranwy Izunitqsdg Cwfvsblx Suzyidmz Sns z ovst Warsaw Poland
Cemtmsv Mnydqvim Jmoibet Sss z ojff Warsaw Poland
Fmsrzyjo nnjtdmgpu Mlrii a Hhqufou Prague Czechia
Cyjkoz Hmmevakfkdy Ryfxbuak Uftlgtyqmmyyt Dt Tbinn Tours France
Uxuplcdxsm Oe Armfexy Edegem Belgium
Ftycxdqcn Prfi Lt Iufodljqbbdbh Bweqddrxc Dyq Hlspmeel Uksrxlomdmbay Lq Pej Madrid Spain
Hysnmfobo Zixlcbu fpkc Kxdjpjn ubt Juqjmkqbdacrnvmtrep Hamburg Germany
Hptlmoza Vxzr dyfvexds Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.01.2026
Bulgaria Bulgaria
Not yet recruiting
01.01.2026
Czechia Czechia
Not yet recruiting
01.01.2026
France France
Not yet recruiting
01.01.2026
Germany Germany
Recruiting
01.01.2026
Greece Greece
Not yet recruiting
01.01.2026
Hungary Hungary
Not yet recruiting
01.01.2026
Italy Italy
Not yet recruiting
01.01.2026
Poland Poland
Recruiting
01.01.2026
Spain Spain
Not yet recruiting
01.01.2026

Trial locations

Investigated drugs:

Filgotinib is a medication taken by mouth that is being studied to see how safe and effective it is for children and teenagers with a type of juvenile arthritis. It works by targeting specific parts of the immune system to help manage the condition.

Investigated diseases:

Polyarticular juvenile idiopathic arthritis – This is a type of chronic inflammation that affects children and adolescents. It is characterized by the involvement of five or more joints. The condition often causes swelling, pain, and stiffness in the affected areas. As it progresses, the inflammation can lead to persistent discomfort and changes in joint movement. It is considered one of the more widespread forms of juvenile arthritis.

Trial ID:
2024-511593-70-00
Protocol code:
GLPG0634-CL-329
Trial Phase:
Therapeutic confirmatory (Phase III)

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