Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the long-term safety and effects (good and bad) of abatacept on your child‘s Juvenile Idiopathic Arthritis (JIA).
The U.S. Food and Drug Administration (FDA) have already approved abatacept for the treatment of JIA.
Who can participate?
Children and teens, 2 to 17 years old, who are:
- Diagnosed with JIA
- Prescribed abatacept as part of their medical care for treating JIA
What will happen in the study?
If your child qualifies, and you decide you want them to participate, your child will be followed in the registry for up to 10 years.
Information for the registry will be collected through clinic visits and at the time the physicians are notified of the events of interest.
You and your child will first have a baseline visit, lasting about 1 hour, to collect information and go over the informed consent. This is a form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
Additional data for the study will be collected from you and your child at visits over the next 10 years. Each of these registry study visits, each lasting about 1 hour, will happen:
- Every 3 months during the first year of the registry (about 3 visits)
- Every 6 months during years 2 through 5 (about 8 visits)
- Every year during years 6 through 10 (about 5 visits)
Tests and procedures that can occur during one or all of the study visits are:
- Review of your child’s patient records to collect demographics (birth, gender, race/ethnicity)
- Your child’s height and weight will be recorded
- Review of your child’s medical history (including any chronic illnesses, reasons for any hospitalizations in the previous year, family history of autoimmune disorders, JIA subtype, and previous JIA therapies)
- Record and review medication usage (including abatacept)
- Record abatacept dosing and start date
- Physician will perform joint assessment and assess disease activity
- Patient questionnaires (each should take about 10 minutes)
- Your child will be asked to provide a blood sample (if you agree to have your child’s blood tested)
- You will be asked about your child’s last exam for uveitis assessment
- You and your child will be asked about any illnesses or infections since the previous visit (all autoimmune disorders, malignancies, and serious infections will be recorded as well as other events)
Please note that once your child has received at least 4 months of abatacept, he or she will remain in the registry regardless of whether or not he or she stops taking the drug.
Patients turning 18 years of age will be asked to sign an adult consent and continue to be followed in the registry until they have completed the 10 year follow-up period.
What are the bad things that can happen from this research?
There are no risks to your child from answering questions about his or her JIA. There may be risks from the medication(s) your child’s doctor prescribes to treat your child’s JIA. However, the prescribing of your child’s medication will be based on a clinical decision made by you and your child’s doctor. That decision will be made independent of this research study.
A detailed list of possible side effects for this research study will be provided to those participants, parents or guardians interested in knowing more about this study.
Will you/your child be paid to be in this research study?
You will receive $50 per registry study visit for the time and travel associated with your child’s participation.