Study on the Effects and Safety of Upadacitinib for Children with Polyarticular Juvenile Idiopathic Arthritis

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What is this study about?

This clinical trial is focused on studying a condition known as Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA), which is a type of arthritis that affects children and involves inflammation in multiple joints. The study is testing a medication called Upadacitinib, which is a Janus kinase (Jak) 1 inhibitor. This medication is being tested in two forms: an oral solution and a modified-release tablet. The purpose of the study is to understand how the body processes the medication, as well as to assess its safety and how well it is tolerated by children with pcJIA.

Participants in the study will receive multiple doses of Upadacitinib over a period of time. The study will monitor how the medication is absorbed and processed in the body, as well as any side effects that may occur. The study will also look at the long-term safety of the medication for those who continue with the treatment after the initial phase. Additionally, the study will evaluate how effective the medication is in managing the symptoms of pcJIA.

Throughout the study, researchers will also assess the taste of the oral solution form of Upadacitinib to ensure it is acceptable for children. The study aims to provide valuable information on the use of this medication in young patients with pcJIA, potentially offering a new treatment option for managing this condition.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, the participant’s eligibility will be confirmed based on specific criteria, such as age, weight, and medical history related to polyarticular course juvenile idiopathic arthritis (pcJIA).

The participant will undergo a physical examination, and any current medications will be reviewed to ensure they meet the study requirements.

2 medication administration

The participant will begin taking the study medication, upadacitinib. This medication is available in two forms: an oral solution and a modified-release tablet. The specific form and dosage will be determined by the study team.

The medication will be taken orally, and the frequency and duration will be specified by the study protocol. Participants will be instructed on how to take the medication correctly.

3 regular follow-up visits

Participants will attend regular follow-up visits to monitor their health and the effects of the medication. These visits will include physical examinations and discussions about any side effects or changes in symptoms.

Blood samples may be taken to evaluate the medication’s effects on the body and to measure its concentration in the blood.

4 evaluation of medication effects

The study will assess the pharmacokinetics of upadacitinib, which involves understanding how the medication is absorbed, distributed, metabolized, and excreted by the body.

Participants may be asked to provide feedback on the palatability of the oral solution form of the medication.

5 long-term safety assessment

The study will continue to evaluate the long-term safety and tolerability of upadacitinib in participants who complete the initial phase of the study.

Participants will be monitored for any long-term side effects or changes in their condition.

6 completion of study

Upon completion of the study, participants will have a final visit to assess their overall health and the outcomes of the study.

Participants will receive information about the study results and any further steps if necessary.

Who Can Join the Study?

Individuals must be between the ages of 2 and less than 18 years old and weigh at least 10 kg (about 22 pounds) at the time of screening.
Must have been diagnosed with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA), which includes:
- Rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA
- Extended oligoarticular JIA
- Systemic JIA with active arthritis but without active systemic features
Arthritis must affect at least 5 joints within the first 6 months of the disease. For extended oligoarticular JIA, 4 or fewer joints within the first 6 months and more than 4 joints thereafter.
Must not have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
Must have 5 or more active joints at the time of screening. Active joints are defined as:
- Swollen joints (not due to deformity)
- Joints with limited movement plus pain on motion and/or tenderness when touched, with limited movement in at least three of the active joints
If taking methotrexate (MTX), must have been on it for at least 12 weeks before the study starts and on a stable dose for at least 8 weeks before the study starts. Also, should take either folic acid or folinic acid as per local standard care.
If taking oral glucocorticoids (a type of steroid medication), must have been on a stable dose (no more than 10 mg/day or 0.2 mg/kg/day, whichever is lower) for at least 1 week before the study starts.
Must not have had any prior exposure to a JAK inhibitor (a type of medication).

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently taking other medications that might affect the study results.
Patients who have had a recent infection or illness that could impact their participation.
Patients who have a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures or attend all required visits.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with a mental health condition that could affect their ability to participate.
Patients who have had a recent surgery or are planning to have surgery during the study period.

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

Other Sites

Site Name	City	Country
St.-Josef-Stift	Sendenhorst	Germany
Semmelweis University	Budapest	Hungary
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin	Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Hvnobpibg Zuzydmw fccr Kweayqy uth Jdodixxwwgeizkckysm	Hamburg	Germany
Fnzfsymtr Ptog Ln Iywxfelvybtzk Bhvaervjg Dib Hxoxekqn Uciedxpkfuolt Ly Pcg	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	11.09.2018
Hungary	Not recruiting	11.09.2018
Italy	Not recruiting	11.09.2018
Spain	Not recruiting	11.09.2018
Sweden	Not recruiting	11.09.2018

Trial locations

Investigated drugs:

Upadacitinib

Upadacitinib is a medication being studied for its effects on children with a type of arthritis called polyarticular course juvenile idiopathic arthritis (pcJIA). This condition causes joint pain and swelling. Upadacitinib works by blocking certain proteins in the body that can lead to inflammation and joint damage. The goal of this study is to see how the body processes the medication, to check if it is safe for children to use, and to understand how well it helps in reducing the symptoms of arthritis over time.

Investigated diseases:

Juvenile idiopathic arthritis

Polyarticular Course Juvenile Idiopathic Arthritis – This disease is a type of juvenile idiopathic arthritis that affects five or more joints within the first six months of the disease. It commonly involves both large and small joints, including those in the hands, feet, knees, and ankles. The condition is characterized by persistent joint inflammation, leading to pain, swelling, and stiffness. Over time, the inflammation can cause joint damage and affect the child’s growth and physical development. The disease may also cause systemic symptoms such as fatigue and fever. It is a chronic condition that can vary in severity and progression among individuals.

Trial ID:

2023-505060-11-00

Protocol code:

M15-340

NCT ID:

NCT03725007

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects and Safety of Upadacitinib for Children with Polyarticular Juvenile Idiopathic Arthritis

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