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Long-Term Study of Tofacitinib for Children and Teens with Juvenile Idiopathic Arthritis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a medication called tofacitinib for treating a condition known as Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children, causing joint pain and inflammation. The medication being tested, tofacitinib, is a Janus Kinase (JAK) inhibitor, which means it works by blocking certain enzymes in the body that are involved in the inflammation process. The study aims to understand how safe and tolerable tofacitinib is for children with JIA over an extended period.

Participants in the study will receive tofacitinib in either a film-coated tablet or an oral solution form. The study will last for up to 120 days, during which participants will take the medication daily. Throughout the study, regular check-ups will be conducted to monitor the participants' health, including their growth and physical development. These check-ups will involve standard laboratory tests and assessments of any side effects that may occur.

The study will also evaluate how well the medication is working by looking at various health indicators. These include the number of joints with active arthritis, the level of inflammation in the body, and overall physical function. Additionally, the study will assess the participants' overall well-being and any changes in their arthritis symptoms. The goal is to gather comprehensive information on the long-term use of tofacitinib in managing the symptoms of JIA in children.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study related to juvenile idiopathic arthritis (JIA).
Eligibility includes being between 2 and 18 years old and having sufficient JIA activity to use tofacitinib.
Step 2
Initial assessment
An initial assessment is conducted to ensure no active or inadequately treated tuberculosis (TB) infection.
Disallowed medications must be discontinued before starting the study drug.
Step 3
Medication administration
The study involves taking tofacitinib as an oral solution.
If receiving methotrexate (MTX), the dose should not exceed 25 mg per week or 20 mg per square meter per week, whichever is lower.
If taking oral glucocorticoids, the maximum dose is 0.20 mg per kg per day or 10 mg per day of prednisone or equivalent, whichever is lower.
Leflunomide, sulfasalazine, chloroquine, or hydroxychloroquine may be used according to local standards.
Step 4
Regular follow-up visits
Regular visits are scheduled to monitor safety and tolerability of the medication.
Standard laboratory tests and assessments of growth and physical development are conducted.
Physician evaluations and assessments of joint activity and inflammation are performed.
Step 5
Assessment of treatment effects
Evaluations include the number of joints with active arthritis and limitation of motion.
Inflammation markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) are measured.
Childhood Health Assessment Questionnaire (CHAQ) and parent's assessments of physical function, arthritis pain, and overall wellbeing are completed.
Step 6
Long-term monitoring
The study aims to determine the long-term safety and tolerability of tofacitinib for JIA treatment.
The study is expected to continue until March 22, 2025.

Who can join the trial?

12 criteria

Children and teenagers aged 2 to less than 18 years with **Juvenile Idiopathic Arthritis (JIA)** who have enough disease activity to use the study medication, tofacitinib.
Willing and able to attend all scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.
In the doctor's opinion, treatment with tofacitinib is suitable for the participant.
No signs of active **tuberculosis (TB)** or untreated TB infection, whether active or hidden.
Stopped using any medications not allowed in the study for the required time before starting the study medication and only using allowed medications in the correct doses.
Participants who can have children and are sexually active must use a highly effective birth control method during the study and for at least 28 days after the last dose of the study medication.
Previously completed participation in a qualifying JIA study of tofacitinib.
If taking **methotrexate (MTX)**, it must be taken by mouth or injection at doses not more than 25 mg per week or 20 mg per square meter per week, whichever is lower. Must also take folic acid or folinic acid as per local guidelines.
If taking an oral **glucocorticoid**, it must be at a maximum dose of 0.20 mg per kg per day or 10 mg per day, prednisone or equivalent, whichever is lower. For certain subjects, a higher prednisone equivalent dose may be continued or started.
If taking **leflunomide**, it must be at the following doses: 10 mg every other day for those weighing 40 kg, or as per local guidelines.
If taking **sulfasalazine**, **chloroquine**, or **hydroxychloroquine**, it must be administered according to local guidelines.
Must have a signed and dated informed consent document, with assent if appropriate, indicating that the participant or their legal representative has been informed about all aspects of the study.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication or similar medications.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals.
Patients who have been diagnosed with any other autoimmune disease, which is when the body's defense system attacks its own healthy cells.
Patients who have received any live vaccines within the last 4 weeks. Live vaccines contain a small amount of the actual virus or bacteria.
Patients with a history of cancer, except for certain types of skin cancer that have been treated and are not active.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients with certain blood disorders, which are problems with the blood cells or how the blood works.
Patients with severe liver or kidney disease, which are conditions affecting the organs that filter waste from the body.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Y Politecnico La Fe
Verified
Valencia, Spain
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Tofacitinib is a medication being studied for its long-term safety and effectiveness in treating juvenile idiopathic arthritis (JIA). It works by helping to reduce inflammation and alleviate the symptoms associated with this condition.

What is already known about the treatment

Tofacitinib – Tofacitinib is administered orally in tablet form and is currently being studied for its long-term safety and tolerability in treating Juvenile Idiopathic Arthritis (JIA). It is an established medication in medical literature, primarily used for conditions like rheumatoid arthritis. The main therapeutic indication for tofacitinib in this study is to manage the signs and symptoms of JIA. At the molecular level, tofacitinib works by inhibiting Janus kinases (JAKs), which are enzymes that play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Juvenile Idiopathic Arthritis (JIA) – 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, JIA can impact a child's growth and physical development. The condition can vary greatly in severity and duration, with some children experiencing symptoms for only a few months, while others may have symptoms for many years. Regular monitoring of joint activity and inflammation levels is essential to understand the progression of the disease.