What will happen in the study?
If your child qualifies and you decide you want them to participate, your child will come to Cincinnati Children’s once every 4 weeks for 28 weeks and then once every 8 weeks in the following 4.5 years (for a total of 38 visits). Extra visits may be scheduled if needed.
These are the tests, procedures and assessments that will be completed during one or more study visits, including the screening:
- Review of your child’s medical history
- Review of your child’s past and present medication history: including all prescription and over-the-counter drugs, vitamins, herbs, and other kinds of therapies
- Physical and skin examination
- Joint examination: evaluation of your child’s joints for range of movement, pain, tenderness and swelling
- Uveitis (inflammation of the eye) evaluation: a physical exam and interview completed by the study doctor and/or a qualified eye doctor (the study doctor will determine how often this is done, if at all)
- Vital sign measurements: including weight, height, blood pressure, breathing rate, pulse rate and temperature
- Collection of blood samples for laboratory tests
- Tanner staging for sexual maturity assessment: evaluation of your child for physical signs of sexual maturity
- Tuberculosis evaluation: you will be asked a series of questions to evaluate if your child has any signs or symptoms of active TB (this may occur at regular visits or through a telephone call)
- Tuberculosis (TB) skin test: a small needle with a solution is injected under the skin to test for TB and then you and your child will need to return 48 to 72 hours after the test to read the results (given if the TB blood test is not approved)
- Chest X-ray: to make sure your child’s heart and lungs are working properly and there are no infections or other problems (the study doctor will determine if this is needed)
- Child Health Assessment Questionnaires (CHAQ): you or your child will rate the degree of difficulty your child has in performing daily living tasks; rate your child’s overall wellbeing and how arthritis affects your child; rate the average pain your child has had during the past weeks before visits
- Physician global assessment of disease activity: an evaluation of the current arthritis activity of your child
- Discussion of any symptoms (side effects or other problems) between study visits while your child is on the study drug
Your child will first have a Screening Visit to determine if he or she is eligible to participate in this research study. The Screening Visit will take place 6 weeks before your child can begin taking the investigational study drug golimumab. Study staff will review the consent form and receive your consent and/or your child’s assent (when required) before continuing on with the study.
If your child is eligible to continue in the study after the Screening Visit, he or she will begin to receive the golimumab through an infusion (or an IV) at selected study visits. The golimumab will be put into a vein in your child’s arm through a small tube attached to a needle.
Your child will receive the first and second infusions each 4 weeks apart (2 infusions in 8 weeks). After the second infusion, your child will receive golimumab once every 8 weeks.
Each infusion will take about 20 to 40 minutes. After each infusion, you and your child will need to stay at Cincinnati Children’s for 60 minutes to check for side effects.
After a year (52 weeks), your child will begin the Long Term Extension (LTE) period of the study. During the LTE, which lasts about 3 years and 8 months (192 weeks), you and your child will have 1 visit every 8 weeks, or about 24 visits, at Cincinnati Children’s.
At the end of the study, you and your child will return for your final visit, or the Safety Follow-up Visit. This will happen about 8 weeks after your child’s last dose of golimumab.
Parents/guardians interested in having their child participate will be given a consent 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.
What are the good things that can happen from this research?
Your child may or may not receive any direct benefit from participating in this research study. Doctors are not yet sure whether this medicine will work to treat your child. However, your child’s participation in this study may help treat other people with JIA in the future.
After your child’s participation in this study has ended, he or she will continue to receive the study medicine, under specific conditions. Your doctor will explain those specific conditions to you and make sure you do not have any questions.