Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A3921145 - A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

This ongoing study is specifically for young people with juvenile idiopathic arthritis (JIA) who are taking a medication called tofacitinib. It's designed to see how safe the medication is over a long time and how well it helps control their arthritis. Researchers will regularly check things like their growth (height and weight), overall physical development, and any side effects. They will also look at how much pain they have, how well they can move their joints, and how active their arthritis is. This helps doctors understand the long-term impact and effectiveness of tofacitinib in managing JIA.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Pfizer Inc.

Enrolment target

Start

17 Jun 2024

Juvenile Idiopathic Arthritis (JIA)

What is this study about?

This study, called A3921145, is designed to understand more about a medicine called tofacitinib when used for juvenile idiopathic arthritis (JIA). JIA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness.

The main goal of this study is to look at the long-term safety of tofacitinib. This means doctors will be carefully checking for any side effects and how the medicine affects a young person's health over time. They will also be monitoring their physical development, such as growth in height and weight, and how their body matures.

Beyond safety, the study also wants to see how well tofacitinib helps manage JIA. This includes understanding how much it reduces pain, improves joint movement, and lowers inflammation in the body. Researchers will also look at how it affects their overall health and daily activities, helping to paint a full picture of the medicine's long-term effects.

Key takeaways

This study looks at the long-term safety of tofacitinib for JIA.
It also checks how well tofacitinib helps manage JIA symptoms.
Young people with JIA who are on tofacitinib may be eligible.
Regular health checks, blood tests, and questionnaires are part of participation.
The study monitors overall growth and physical development.
Joining helps doctors learn more about JIA treatment for the future.

Who may be eligible?

This study is for young people who have been diagnosed with Juvenile Idiopathic Arthritis (JIA).

If you are currently taking or have been prescribed the medicine tofacitinib for your JIA, this study might be suitable for you.

There are no specific age limits mentioned, meaning that young people of any age with JIA who meet other criteria might be able to take part. The study is open to both boys and girls.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have Juvenile Idiopathic Arthritis (JIA)?
Are you currently taking tofacitinib for your JIA?
Are you prepared for regular check-ups and assessments?
Are you or your child open to completing health questionnaires?
Are you comfortable with doctors monitoring growth and development?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive tofacitinib as prescribed for your JIA. You will have regular visits with the study team. At these visits, doctors will collect routine safety information, such as blood tests, to make sure you are feeling well and that the medication is not causing any unexpected problems.

They will also measure your height and weight, and check your physical development. You, or your parent/guardian, will be asked to complete questionnaires about your pain, daily activities, and how you are feeling generally. Doctors will also check your joints for swelling or stiffness. The study is designed to follow you over a long period to understand the effects of the medication over time.

Potential risks and benefits

Taking part in a study like this can offer the potential benefit of closer monitoring of your health and JIA management while on tofacitinib. You will be helping doctors learn more about this medication, which can help other young people with JIA in the future. As with any medication, there can be potential risks from side effects, which the study team will monitor closely. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Belgium
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Unverified
Poland

Common questions

What is Juvenile Idiopathic Arthritis (JIA)?

JIA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness.

What is tofacitinib?

Tofacitinib is a medication used to treat certain inflammatory conditions, including JIA.

What does 'long-term, open-label follow-up' mean?

It means the study will follow people for a long time, and everyone knows they are receiving the medicine being studied (tofacitinib).

Will I get 'new' medicine in this study?

This study is for people already taking tofacitinib for JIA; it's about following its long-term effects and safety.

Why are they checking my height and weight?

Researchers want to see how tofacitinib might affect growth and physical development over time.