Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis

3 1 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called baricitinib in treating a condition known as Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children, causing joint pain and inflammation. The study involves participants aged 1 to less than 18 years who have previously been treated with baricitinib for JIA.

The purpose of the study is to determine if baricitinib is safe and effective for children with JIA. Participants will receive the medication in the form of a tablet or oral suspension, which means it is taken by mouth. The study will monitor the participants over a period to observe any side effects and to see how well the medication works in managing the symptoms of JIA.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of baricitinib. The study aims to gather information on the number of participants who experience serious side effects or need to stop taking the medication permanently. This information will help in understanding the long-term use of baricitinib in treating JIA in children.

1 joining the study

Participation begins after completing a previous study of baricitinib for juvenile idiopathic arthritis.

Eligibility requires no allergy to baricitinib.

2 medication administration

Baricitinib is administered orally.

The medication is available in tablet form or as an oral suspension.

Dosage and frequency are determined by the study protocol and the participant’s specific needs.

3 monitoring and evaluation

The study aims to evaluate the long-term safety and effectiveness of baricitinib.

Participants are monitored for any serious adverse events (SAEs).

The number of participants who discontinue the investigational product permanently is recorded.

4 study duration

The study is estimated to conclude by December 18, 2030.

Participants will be involved in the study until its completion or until they meet criteria for discontinuation.

Who Can Join the Study?

  • Participants must have completed a previous study of the study drug, baricitinib, for the treatment of Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children.
  • Participants must not have developed an allergy to baricitinib. An allergy is when your body reacts badly to something, causing symptoms like itching or swelling.
  • Participants must be between the ages of 1 and 17 years old.
  • Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
IRCCS Istituto Giannina Gaslini Genoa Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Universita Degli Studi Di Brescia Brescia Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Bicetre Hospital Le Kremlin-Bicetre France
Zentrum für Kinder- und Jugendrheumatologie Hamburg Germany
Ccyzyndpw Uzdehpyfycxeuy Sgvlrcfmr Woluwe-Saint-Lambert Belgium
Llj Bijfbab Bregenz Austria
Sgislbf Dzerikpaj Sdr Lffpasa Iwh Onlxpbt Knglfievo Pwvmsxdlm Rjxpivbwuytq z ppcljdgpdoea aworrprqvg Cracow Poland
Falwrrkv nuiaagork Muauh a Huehufa Prague Czechia
Aeatmi Unlyxemjac Hnvphzjo Aarhus Denmark
Srxrrxurgno Pjjgfxnke Ztpibr Ofsllh Zcuiwukrfp Cqghsumqt Scnqjqd Ktpzojnfh Ugfpuffjjlwx Mdshdwtlcz W Lokgn Lodz Poland
Fnqtncjie Pfey Lo Inwoufhnzpvaj Bgeawggeq Dqr Hwcpbpvm Uzkuzeayrixev Lo Psh Madrid Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
24.10.2019
Belgium Belgium
Recruiting
24.10.2019
Czechia Czechia
Recruiting
24.10.2019
Denmark Denmark
Not recruiting
24.10.2019
France France
Recruiting
24.10.2019
Germany Germany
Recruiting
24.10.2019
Italy Italy
Recruiting
24.10.2019
Poland Poland
Recruiting
24.10.2019
Spain Spain
Recruiting
24.10.2019

Trial locations

Investigated drugs:

Baricitinib is a medication being studied for its safety and effectiveness in treating Juvenile Idiopathic Arthritis (JIA) in children and adolescents aged 1 to 17 years. It works by targeting specific pathways in the immune system that are involved in inflammation, which is a key factor in JIA. The goal of the study is to determine if this medication can help reduce symptoms and improve the quality of life for young patients with this condition.

Investigated diseases:

Juvenile Idiopathic Arthritis – This is a type of arthritis that occurs in children under the age of 16. It is characterized by persistent joint inflammation, which can lead to pain, swelling, and stiffness. The disease can affect one or multiple joints and may also cause symptoms such as fever and rash. Over time, it can lead to joint damage and growth problems if not managed properly. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The progression of the disease can vary, with some children experiencing symptoms for only a few months, while others may have symptoms for many years.

Trial ID:
2023-506131-15-00
Protocol code:
I4V-MC-JAHX
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +4
  • A study to evaluate the safety and effectiveness of filgotinib in children and adolescents with juvenile idiopathic arthritis.

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany