The TURTLE study has now closed. We would like to thank everyone who took part. This page provides a summary of the study and its results for participants, their families and the public.

What was the purpose of the study?

The purpose of the TURTLE study was to find out whether a medicine called secukinumab could help control eye inflammation (uveitis) in children and young people with juvenile idiopathic arthritis (JIA).

The study focused on participants whose uveitis had not responded well to standard treatments, including methotrexate and adalimumab. By carrying out this study, doctors hoped to learn whether secukinumab, when given alongside existing treatments, could be an effective alternative treatment option.

Why was I/my child invited?

You or your child was invited to take part because you have juvenile idiopathic arthritis-associated uveitis that had not been adequately controlled with previous standard treatments.

People who met specific medical criteria were invited so that the study could fairly and safely test whether the study medicine might help control uveitis in similar patients in the future.

A total of 10 participants aged between 2 - 18 years with JIA associated uveitis throughout the UK participated in the study.

Which medicines were being tested?

The study tested a medicine called secukinumab. Secukinumab is a biologic medicine that works by targeting part of the immune system involved in inflammation.

Participants received secukinumab in combination with either methotrexate or mycophenolate, which are medicines already commonly used to treat autoimmune and inflammatory conditions.

What happens to me/my child now the study has stopped?

Now that the study has ended, your ongoing medical care will continue under your usual clinical team. Your doctor will discuss the best available treatment options for you or your child based on individual clinical needs.

No further study visits or study medications are required as part of the TURTLE trial.

Are there any side effects that we should report now the study has ended?

During the study we closely monitored any side effects that may be experienced by you/your child. If you or your child experiences any new or ongoing health concerns that you believe may be related to the study medication, you should report these to your usual healthcare team.

Even though the study has ended, it is still important to let your doctor know about any symptoms so they can provide appropriate advice or care.

Will my taking part in the study be kept confidential?

Yes. All information collected during the study has been handled in strict confidence. Your identity has been protected, and your personal details will not be included in any reports or publications.

The study followed UK data protection laws and research regulations to ensure your privacy was always respected.

What were the results of the study and how will they be made available?

In the TURTLE study, all participants took part in Stage 1, where they received secukinumab injections together with either methotrexate or mycophenolate for up to 24 weeks. Participants were closely monitored, with clinic visits every 4 weeks, and a main review point at 12 weeks to see whether the treatment was helping.

After 12 weeks of treatment, we checked whether participants were getting better. Improvement was measured using a scoring system called the Standardization of Uveitis Nomenclature (SUN) score, which is commonly used by eye specialists to measure inflammation inside the eye. The SUN score ranges from 0 to 4+, where:

• 0 means no inflammation
• 4+ means severe inflammation

We said a participant was “getting better” if their SUN score improved by at least two levels after 12 weeks of treatment. For example, if a participant started the study with a SUN score of 4+ and this improved to 2+ or lower at 12 weeks, this was considered a positive response to treatment. Participants who showed improvement could continue taking secukinumab, while those who did not improve stopped the study medicine and were advised by their doctor about other treatment options.

In this study, we planned that at least 3 out of 10 participants would need to show improvement at the 12 week point in order for the study to progress to the next stage and for further research to be recommended. However, only 1 out of the 10 participants showed enough improvement after 12 weeks. Because this target was not met, the study did not continue beyond Stage 1.

Although the study did not meet the criteria needed to continue, the results are still very important. They provide valuable information about how well secukinumab worked for this group of participants and help doctors and researchers understand which treatments may or may not be helpful for children and young people with JIA-associated uveitis. This information can help guide future research and support doctors when making treatment decisions.

The study also provided important information about side effects experienced by participants taking secukinumab, adding to what is known about the safety of this medicine in this patient group.

Have the results of the study been seen by anyone else?

Yes. The results have been reviewed by the study researchers and will be shared with the wider medical and research community through publication and presentations.

This helps ensure that the knowledge gained from the study contributes to future research and patient care.

Novartis, a pharmaceutical company, provided the secukinumab that was used in this study and have also seen the results from the study.

Will I be given any results about me as an individual?

We will not publish any individual results. If you would like to know more about your results during the study please speak to your study nurse or doctor.