Summary Results

What was the purpose of the study?

The purpose of the study was to look at how effective the use adalimumab in combination with methotrexate is compared to using methotrexate (MTX) alone for the treatment of JIA- associated uveitis.

Why was I/my child invited?

You/your child were asked to participate because you/your child had persistently active JIA- associated uveitis. You/your child had also been chosen as you/they were taking methotrexate without an improvement in your/their uveitis since starting it. A total of 90 participants aged between 2 - 18 years with JIA associated uveitis throughout the UK participated in the study.

Which drug/ drugs were being tested?

The study involved the use of either Adalimumab or placebo being given together with methotrexate. We used a placebo in the study so that we could see if adding Adalimumab to treatment with methotrexate was better than using methotrexate on its own. 

Methotrexate is a powerful treatment used to treat young people and children who suffer from JIA- associated uveitis along with other rheumatic conditions. It helps to reduce the activity of the cells which cause inflammation and is used when anti- inflammatory drugs are not enough or in those with moderate or more severe disease.

Even when treated with methotrexate, a number of children still have inflammation of the eye and therefore methotrexate may not work on its own.

Adalimumab is a type of drug known as an anti-TNF (anti- tumour necrosis factor). In children and young people with inflammatory diseases a protein called TNF is overproduced in the body, causing inflammation and damage. Anti-TNF drugs block its action and so can reduce this inflammation.

There were indications that Adalimumab may work in treating uveitis symptoms and it is being used more and more as a treatment, but we did not know at the start of the study if it really works. The only way to test this properly was to carry out a research project called a clinical trial.

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

After you/your child finished taking part in the study, your doctor will have explained what happens next. Your doctor will have treated you/your child according to normal clinical practice. You should have been told whether you/your child received Adalimumab or placebo, if not please contact the doctor or nurse who looked after you whilst you were in the study.

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

As Adalimumab is a relatively new drug, the long-term side effects are not fully understood. During the study we closely monitored any side effects that may be experienced by you/your child and now that the study has finished your doctor has been asked to report any side effects they feel that may be related to Adalimumab. If you/your child are concerned at any time please contact the doctor or nurse who looked after you during the study.

Will my taking part in the study be kept confidential?

Yes. We will follow ethical and legal practice and all information which is collected about you/your child during the course of the research will be kept strictly confidential. All data collected during the trial will be kept for a maximum of 15 years after the trial has ended, during this time all of you/your child’s information will be kept confidential.

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

In the SYCAMORE trial we looked at each patient over 18 months to see how long they could be treated with either Adalimumab and methotrexate or placebo and methotrexate.

If a patient did not show that their inflammation in the eye was getting better during the 18 months the study doctor would tell the patient to stop taking the Adalimumab or placebo.

We found that that those patients who were taking placebo and Methotrexate in the trial stopped taking placebo sooner than those who were taking Adalimumab and methotrexate, this mean that Adalimumab and methotrexate was better at treating inflammation in the eye than methotrexate alone.

Only 27% of patients taking Adalimumab with methotrexate had to stop taking it before 18 months, whereas 60% of those people taking placebo and methotrexate had to stop taking it.

We also found that more patients taking Adalimumab and Methotrexate together either reduced or stopped taking topical steroids compared to the patients taking placebo and Methotrexate together.

We also found that patients taking Adalimumab and Methotrexate together experienced more side effects than those taking placebo and Methotrexate together; the most common side effects were minor infections, respiratory disorders, and gastrointestinal disorders. 

Our final results show that Adalimumab used in combination with methotrexate does help to treat patients with Juvenile Idiopathic Arthritis and Uveitis. The results of this study have made a positive change to how people with JIA-Uveitis are treated by changing NHS England policy. The information we have collected is very important and tells us a lot.

A summary of the results published in the New England Journal of Medicine can be found here - http://www.nejm.org/doi/full/10.1056/NEJMoa1614160 this is a summary of the article, if you want to read the full article you will need to subscribe. The summary of the article is written in a technical language, if you have any concerns or queries please contact your study nurse or doctor. The change to the NHS England policy can be found on the NHS England website https://www.england.nhs.uk/2015/11/adalimumab-child/.   

Have the results of the study been seen by anyone else

A medicine company called AbbVie provided the Adalimumab and placebo for the study. Adalimumab is approved for use here in the UK and America but not for the treatment of JIA-Uveitis. As the results of the study are positive AbbVie would like to apply for a licence for Adalimumab to be used to treat JIA-Uveitis around the world. A licence shows that the benefits of the medicine outweigh the risks. Licences are only given if a medicine has been made and checked to a high standard. The data we have collected in SYCAMORE can help show this. We have shared the results of the study with AbbVie so that they can apply for a licence in America with the Food and Drug Administration (FDA). We have also shared data where patients had a serious adverse event or if a patient withdrew from the study. In these cases, your name was not sent to AbbVie: patients were only identified by study randomisation number, initials and date of birth. We may need to also send this information to other regulatory authorities around the world in the future so that Adalimumab can be licensed to treat JIA-Uveitis in other countries too. If you have any questions, please speak to your study doctor or nurse.

 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.

 Invitation to take part in patient involvement

When research studies like this one are being set up we like to get input from patients into the design of the study and what impact the study may have on patients. We also like to have patient involvement throughout the study.

 Examples of patient involvement include:

-              help make sure researchers ask the right questions

-              help make sure the research design is appropriate

-              help make sure information about the research is easy to understand

-              help make sure reported results are clear and easy to understand

 If this is something you might be interested in doing please visit the following websites which provide general information about patient and public involvement in research including how you can get involved:

The National Institute for Health Research website:

https://www.nihr.ac.uk/patients-and-public/

INVOLVE:

http://www.invo.org.uk/

The Clinical Trials Research Centre, University of Liverpool is keen to ensure patients and the public have the opportunity to be actively involved in research

Contact details

If you have any questions please contact the study nurse or doctor who looked after you during the study.

Thank you

We want to thank you again for taking part in this study. The results of this study have made a positive change to how other patients like you are being treated. We could not have done this without the help and participation of the patients and families that took part in the trial.

 
 




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