Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)
What is adalimumab?
Adalimumab is a type of drug that is called a biologic. It is an effective treatment for JIA-associated uveitis and is taken in the form of a subcutaneous injection.
Why is there a trial?
Many people with JIA take adalimumab to control their joint and eye inflammation. While adalimumab is effective in controlling eye and joint inflammation, there are some risks such as infection associated with the medication. Adalimumab can also be very expensive.
There are no scientific guidelines about when patients may successfully stop taking adalimumb without suffering a recurrence of inflammation. Research is needed to determine whether patients who stop taking adalimumab remain inflammation-free in their eyes and joints and what the predictors are of successfully discontinuing treatment. A clinical trial will be conducted to compare control of eye inflammation (uveitis) and arthritis in patients with JIA who stop adalimumab vs. continue adalimumab.
When does the trial start?
Recruitment for the trial has already started.
Which hospitals are taking part?
The following centers in the US are participating:
Children’s Hospital of Philadelphia
Children’s Mercy Hospital
Cincinnati Children’s Hospital
Colorado Retina Associates, PC and Children’s Hospital Colorado
Johns Hopkins University
Seattle Children’s Hospital
University of California, San Francisco
University of Utah Health
There are hospitals in the UK and Australia that are also participating.
What if my hospital is not listed?
Your child’s doctor will decide whether your child should be transferred to a participating hospital to take part in the trial.
Who has organised this trial?
The University of California, San Francisco is sponsoring this study.
The US National Institutes of Health is providing funding for the trial.
AbbVie, Inc. is providing the donation of adalimumab and placebo.
Who can take part?
Any US resident who is: (1) at least 2 years of age, (2) has been diagnosed with JIA-associated uveitis, (3) has been taking adalimumab for at least 12 months, and (4) has had control of joint and eye inflammation for at least 12 months.
How many people will take part in the trial?
118 people will participate from the US, the UK, and Australia.
Does my child have to take part?
No. Participation is voluntary.
What other information will be given?
You and your child will receive information sheets detailing the trial and what will be involved.
If you do not understand the information that has been given to you, or if you have any questions or concerns, you should talk to your child’s doctor.
How long does the trial last?
Everyone will be followed for 12 months, but some children’s follow-up may be extended to a maximum of 15 months.
What will happen before the trial starts?
After your child’s doctor 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. Your child, if at least 7 years of age, will be asked to sign an assent form.
Some additional questions will be asked about your child’s medical history to ensure they qualify for the trial. Your child may also have their blood drawn, if they have not recently had any bloodwork, to check that they still qualify. This is to ensure that the trial is as safe as possible for your child.
What tests will be done during and after the trial?
- You and your child will be asked about their medical history.
- You and your child will be asked about their quality of life.
- Your child’s height and weight will be measured.
- Your child’s vision will be tested.
- Your child will receive a full front-to-back eye exam.
- Your child will have their joints assessed.
- Girls who have had their first period will have a pregnancy test.
- A blood draw will take place for blood cell counts, liver and kidney function, as well as for antibodies against adalimumab and a protein complex called MRP8/14.
- An optional rectal sample may be collected.
Does every child receive adalimumab?
No. About half of the children will receive adalimumab and the other half will receive a placebo.
Adalimumab will be provided, free of charge, for the remainder of the follow-up period if your child’s inflammation returns and a treatment failure is declared.
What is a placebo?
A placebo imitates medication, but it does not contain any active ingredients.
Will I know if my child is taking adalimumab or the placebo?
No. You, your child, your study doctor, and the study staff will not know whether your child is taking adalimumab or placebo. At treatment failure or at the end of the trial, everyone will find out what your child has been taking. If your study doctor needs to they may find out earlier.
How will my child take the adalimumab or placebo?
Your child will subcutaneously inject the adalimumab or placebo every 2 weeks, just as your child has been doing outside the trial.
What dose will my child receive?
The standard weight-based dose of adalimumab:
If your child weighs less than 30 kg, they will be given 20 mg.
If your child weights 30 kg or greater, they will be given 40 mg.
What happens if my child’s inflammation returns?
If your child’s inflammation returns, the study doctor will safely monitor the inflammation to check that it is sustained—no more than one month. Then you, your child, your study doctor, and the study staff will find out whether your child was taking adalimumab or placebo. Your study doctor will determine the most appropriate next steps.
If your child was taking placebo, they will be encouraged to restart adalimumab (provided by the trial). If your child was taking adalimumab, they may continue to take adalimumab and additional treatment may be added. Adalimumab is provided to all patients free-of-cost for the remainder of their 12-month follow-up period.
Your child will remain in the trial until they complete their 12 months.
Your child’s participation in the trial may be extended up to 15 months if their inflammation returns at the end of the trial. This is for the safety of your child.
What if I change my mind about my child taking part in the trial?
Your child is free 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 your child’s doctor.
What if my child becomes ill during the trial?
If your child comes ill, they should be seen by a doctor and you should inform the study doctor or member of the study team as soon as possible.
What happens when the trial is over?
Your child’s study doctor will help decide how to continue to care for your child following the end of the trial.
Who do I contact if I have a problem?
You should contact your child’s doctor if there are any problems at all. You will be given a card with details of the study and emergency contact numbers that you should carry at all time. Should your child visit a different doctor while taking part in this trial, you should inform them of your child’s participation in the trial. You should also inform the study doctor about this other medical visit.
Will I receive payment?
You may be provided with a small reimbursement to help cover the costs of travel expenses.
Adalimumab will be provided through the end of the trial if your child’s inflammation returns.