Welcome to the SYCAMORE Website

SYCAMORE is a randomised controlled trial of the clinical effectiveness, safety and cost effectiveness of Adalimumab for the treatment of juvenile idiopathic arthritis associated Uveitis.

The SYCAMORE trial has now stopped recruiting new participants. The Independent Data Safety and Monitoring Committee (IDSMC) have reviewed the data collected so far and have stated that we have enough information from the 90 participants who have taken part so far to suggest that Adalimumab helps to treat patients with Juvenile Idiopathic Arthritis and Uveitis. The independent experts have kept the results confidential until SYCAMORE is finished and all of the data can be looked at. All participants that are currently receiving Adalimumab in the trial will continue to receive trial treatment until they have completed the 18 months treatment phase.

Participants who are taking part in the trial or have taken part can find out more information by looking at the frequently asked questions page here or by speaking to your Doctor.


                                     


Information for Participants

University Hospitals Bristol NHS Foundation Trust is the sponsor for this study based in the United Kingdom; they have delegated the day-to-day management of the study to the Clinical Trials Research Centre (CTRC), which is part of the University of Liverpool. We will be using information from you and your medical records in order to undertake this study and University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University will act as the data controllers for this study. This means that University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University are responsible for looking after your information and using it properly. University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University will keep identifiable information about you for 15 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information in the “How we use your information” section at the end of this page.

Your NHS hospital will collect information from you and/or your medical records for this research study in accordance with our instructions.

Your NHS hospital will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from University Hospitals Bristol NHS Foundation Trust, the University of Liverpool, Bangor University and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS hospital will pass these details to the University of Liverpool, Bangor University and University Hospitals Bristol NHS Foundation Trust along with the information collected from you and your medical records. The only people in University Hospitals Bristol NHS Foundation Trust, Bangor University or the University of Liverpool who will have access to information that identifies you will be people who need to confirm your participation in the study or audit the data collection process. The people who analyse the information will not attempt to identify you or find out your name, or contact details.

Your NHS hospital will keep identifiable information about you from this study for 15 years after the study has finished.

University Hospitals Bristol NHS Foundation, the University of Liverpool and Bangor University will collect information about you for this research study from Patient-level costing (PLICS) data from electronic routine NHS health care records. This information will include data on any NHS hospital admissions and health information, which is regarded as a special category of information. We will use this information to analyse the cost-effectiveness of this research study. 

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

How we use your information

The University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University take great care to abide by our legal and moral obligations when handling your personal and healthcare data. Due to changes introduced in the EU General Data Protection Regulation (GDPR), we would like to provide you with information on the lawful basis on which we are processing your data. The lawful basis for the processing of your personal data for the research study which you have participated in is a “task in the public interest”. 

As a NHS organisation/University, the University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University uses personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisations, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officers who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officers can be contacted at

InformationGovernance@UHBristol.nhs.uk

Victoria Heath: LegalServices@liverpool.ac.uk

Gwenan Hine: gwenan.hine@bangor.ac.uk


Sites Counter
Sites Counter
 




I'm fine with this [X]

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.