Tocilizumab (APTITUDE) Trial
What is Tocilizumab?
Tocilizumab is a type of drug that is called a biological therapy. It is usually used for treating rheumatoid arthritis. In this trial Tocilizumab will be given in the form of a subcutaneous injection
Unfortunately some children with JIA-Uveitis do not get better when treated with standard treatment of Methotrexate. There are indications that Tocilizumab may work in treating children with JIA-Uveitis, to find out if this does work there needs to be a project called a clinical trial. This trial will see if there is evidence to show if Tocilizumab does work.
The trial is due to start in November 2015.
Alder Hey Children’s Hospital, Bristol Royal Hospital for Children, Great North Children’s Hospital, Great Ormond Street Hospital, Sheffield Children’s Hospital, Southampton Children’s Hospital.
Your child’s consultant will decide whether or not your child should be transferred to a participating hospital to take part in the trial.
University Hospitals Bristol NHS Foundation Trust has sponsored the study.
It is funded by Arthritis Research UK.
The day-to-day organization is coordinated by the Clinical Trials Research Centre (CTRC) in Liverpool.
Olivia’s Vision (OV) is a charity which was founded to support uveitis patients and their families.
OV was asked by (CTRC) to provide support and information to both the children and their parents considering taking part in the trial.
We will continue to provide that assistance throughout the trial and when the trial is finished.
Olivia’s Vision is an independent charity, which can therefore give impartial and confidential advice.
Any UK resident child aged between 2-18 years with persistently active JIA associated uveitis can be asked to participate.
A total of 22 participants will take part in the trial.
No. Participation is voluntary.
As the parents or guardian you will receive information sheets detailing the trial and what is involved for your child.
Your child (age dependent) will also be given information to ensure that they understand what will be happening, and that they are happy to take part.
If you do not understand the information, or you have any questions or concerns, you should speak to your GP, consultant or Olivia’s Vision.
Each participant will take part in the trial for a maximum of 9 months.
After your child’s specialist has asked whether you would like your child to take part in the trial, you will be given some information sheets.
Once you have had an opportunity to discuss the trial, and all of your questions and concerns have been addressed, you will be asked to sign a consent form.
If your child is over the age of 6 s/he will be asked to sign an assent form.
Your child will then have some tests, known as screening to see if they qualify to be on the study. This is to ensure that the study is as safe as possible for your child
- Your child will have a full physical and eye exam.
- You and your child will be asked about their medical history.
- Blood pressure, pulse, temperature, height and weight will be noted.
- A skin test will take place to screen your child for tuberculosis.
- A blood test will be done.
- Urine will be taken.
- A puberty-stage assessment will be carried out to assess and monitor your child’s physical development. The parent will carry this out.
- If your daughter has had her first menstrual period, she will have a pregnancy test at the screening visit and at months 3, 6, 9, 12, 15, 18 and 21 covering the time during the Trial and for three months after the Trial
Throughout the trial your child will be asked to visit the clinic regularly to have their blood pressure, blood, urine and vision tested.
Your child will have their general health assessed, and you and your child will be asked to keep a diary and to fill in some questionnaires to describe how you are all feeling.
When the study has stopped after 6 months, your child will continue to be seen and assessed after 3 months
Yes, everyone will be given Tocilizuab
They can be removed from the trial and alternative treatment discussed with you according to best practice at their hospital.
You are free for your child to leave the trial at ANY time. It is perfectly normal to have second thoughts, and if you need to talk about your concerns please contact Olivia’s Vision, your GP or consultant.
If your child becomes ill s/he should be seen by a doctor, and the study doctor or member of the study team should be informed as soon as possible.
You should contact your doctor if there are any problems at all. You will be given a card with details of the study, and emergency contact numbers which you will be asked to carry with you at all times. Should your child have to visit a different doctor tell them your child is taking part in this Trial, and that the study doctor should be contacted.
You can also contact Olivia’s Vision http://oliviasvision.org/about/contact-us/ if you need further assistance.
However, if you and your child have to make extra study visits, or go to a hospital further away from the one you would normally go, then reasonable travel expenses can be reimbursed on production of valid receipts.