Frequently Asked Questions

Question

Why has recruitment to the trial been stopped early?

Recruitment has been stopped because the information gathered so far from the 90 people that have taken part in the trial suggest that Adalimumab appears to be effective in the treatment of patients with Juvenile Idiopathic Arthritis and Uveitis.

  

I’m currently on the trial – what will happen next with my medication?

If you are on the trial and have been receiving the drug, you will continue to receive the drug for the 18 months treatment phase of the study as planned and then the 6 month follow up phase will also continue as planned.

 

If you have been receiving the placebo then this will stop and your doctor will discuss your next steps and treatment on an individual basis.

 

 I’ve just finished the treatment phase of the trial and I’m being followed up – do you still need me to attend?

Yes please! It’s really important that we continue to collect your data as planned to ensure that the study has the most amount of data available from those that participated.

 

 I’ve already finished the trial – do I need to do anything?

No – but thank you very much for taking part. Your doctor who looked after you during the study will be able to tell you which treatment you were receiving.

  

When will I find out if I was on the real drug or the placebo?

If your next study visit is quite soon, you will have that as normal and then be told afterwards. If it is some time before your next study visit, you may be asked to come in sooner.

 

 Can I get the drug from my consultant?

You should discuss your individual treatment with your Doctor.

 

 Can I get the drug even though I was on the placebo in the trial?

You should discuss your individual treatment with your Doctor.

 

 Is the drug now approved for treating Uveitis?

Once the results of the trial are published, it may be that Adalimumab will be approved for use in treating children with Uveitis. All of the assessments and paperwork required mean that this can take a long time and as yet we don’t have a clear idea of when this might happen, and we don’t have any control over the approval process.

 

 Was the SYCAMORE study a success then?

Until the results are formally published, we cannot say, however the results suggest that Adalimumab appears to be effective in the treatment of patients with Juvenile Idiopathic Arthritis and Uveitis.

 

 Can my friend get the drug even though they weren’t eligible for the trial?

Requirements for participation in a clinical trial have to be very specific to ensure that the results are consistent. Your friend is no more or less entitled to the drug even though they were not eligible for the trial; however drug availability and its suitability for them needs to be discussed with their Doctor.

 

 Can my friend get the drug even though they / their parents didn’t want to be involved in the trial?

Your friend is no less entitled to the drug for not choosing to be involved in the trial. However, drug availability, their suitability and individual treatment plan needs to be discussed with their Doctor.

 

 What are the side-effects of the drug?

Adalimumab affects the immune system (the body’s own defence system), so you may be more likely to develop infections.

  

Can the drug only be taken with Methotrexate?

There are different ways that Adalimumab can be taken, your Doctor will be able to give you more information on this.

  

What’s the difference between Humira and Adalimumab?

There is no difference – Humira is a brand name of Adalimumab (just like Nurofen is a brand name for Ibuprofen).

  

Are there any more trials taking place?

There may be trials running in your area, the best person to speak to is your Doctor, they will be able to let you know if there are trials running locally that you may be able to take part in.

  

How can I get involved in research in the future?

You may be asked to take part in future research studies by your Doctor, you can also ask your Doctor if there are research studies that are currently running and also express interest in any future research studies.

 
 




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