Humira Trial

Humira (medical name Adalimumab) is a type of drug known as an anti-TNF (anti-tumour necrosis factor).

In children with inflammatory diseases, the body over produces a protein called TNF.  This causes inflammation and damage.  Anti-TNF drugs such as Humira block the protein and so can reduce this inflammation.

Despite current screening and drug options 10-15% of children with JIA associated uveitis may eventually go blind.  There are indications that Humira may work in treating uveitis symptoms and it is increasingly being used as a treatment.

To find out if Humira really does work there has to be a research project called a clinical trial.  This trial will compare the effectiveness of adalimumab with methotrexate (MTX) versus MTX alone.

Recruitment for the trial will begin in September 2011.

The following hospitals are taking part:

• Royal Aberdeen Children’s Hospital
• Alder Hey Children’s Hospital, Liverpool
• Royal Belfast Hospital for Sick Children
• Birmingham Children’s Hospital
• Bristol Children’s Hospital
• Royal Hospital for Sick Children, Edinburgh
• Royal Hospital for Sick Children, Glasgow
• Leeds General Infirmary
• Great Ormond Street Hospital, London
• Royal Manchester Children’s Hospital
• Great North Children’s Hospital, Newcastle
• Norfolk and Norwich University Hospital
• Nottingham Children’s Hospital
• Nuffield Orthopaedic Centre, Oxford
• The Children’s Hospital, Sheffield
• Southampton General Hospital

Your child’s consultant will decide whether 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 the National Institute for Health Research Health Technology Programme (NIHRHTA) and Arthritis Research UK.
• The day-to-day organization is coordinated by the Medicines for Children Research Network Clinical Trials Unit (MCRNCTU) in Liverpool.

Olivia’s Vision (OV) is a charity which was founded to support uveitis patients and their families.

OV was asked by (MCRNCTU) 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.

Everyone affected by uveitis, children and adults, is free to use our Forum and Helpline.

Any UK resident child aged between 2-18 years with persistently active JIA associated uveitis can be asked to participate.

A total of 154 children who are currently on MTX and who have not had any improvement in their uveitis since starting MTX will take part.

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.

Your child will be given the Humira or placebo for a maximum of 18 months, and will then be monitored for a further 18 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 18 months, your child will continue to be seen and assessed every 3 months for a further 18 months.

NO.

Your child will be assigned by chance to either receive the placebo or the Humira.  For every 1 child given a placebo, 2 children will receive Humira.  Every child will continue to be given a stable dose of MTX whether or not they receive the Humira.

A placebo is a dummy drug.  It contains no active ingredients.

NO.

This study is called a “double blinded” trial, which means that neither you nor the study doctor and staff will know whether your child is receiving the Humira or not, although your doctor can find out if s/he needs to.

One or the other will be injected subcutaneously every 2 weeks.  Your child will receive their first dose at the clinic.

Thereafter you or your child will be trained to prepare and administer the medication at home.  If you would prefer to attend the clinic for the fortnightly injection, that can be arranged.

• For patients weighing less than 30kg, a dose of 20mg will be given.
• For patients weighing 30kg or more a dose of 40mg will be given.

They can be removed from the trial and alternative treatment discussed with you according to best practice at their hospital.  They would still be monitored for a further 18 months to assess any side effects.

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.

• Humira affects the immune system and might make your child more likely to develop infections.
• Very rarely Humira can cause drug-induced lupus; the condition usually disappears once treatment is stopped.
• Some children have allergic reactions to drugs. Most reactions occur within 2 hours of the drug being given.
• Humira can cause redness, swelling and pain at the site of the injection.
• It is possible that there may be a slightly increased risk of certain types of cancer in patients using anti-TNF drugs. This link has not yet been proven but is the subject of current research.

Please discuss any concerns with your child’s research doctor. If you need to talk further about any issues please contact Olivia’s Vision.

If your child has benefitted from being on Humira, then there will be a case for the local PCT to fund the drug.  This would be the decision of your child’s local hospital and treating consultant.

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 if you need further assistance.

NO.

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.