The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis (OPT-JIA)
Summary
Far too many kids and families live in dread over the weekly nausea and vomiting caused by methotrexate - a medicine that controls joint swelling in Juvenile Arthritis patients. If
methotrexate is not tolerated, expensive alternative biological medications may be started. This registry-based pragmatic randomized controlled trial will evaluate if routine
premedication with the anti-emetic drug Ondansetron, reduces nausea and vomiting and increases the proportion of children able to continue methotrexate. By preventing nausea
before it starts, we hope to give kids and families a better quality of life and see a more cost-effective use of medication.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 4 to 16
Inclusion criteria:
1) Age 4 -16 years old
2) Diagnosis of JIA as per ILAR criteria
3) Participating in the CAPRI JIA Registry
4) Starting methotrexate for the first time to control JIA
manifestations
5) Informed written consent to participate
Exclusion criteria:
1) Previous use of methotrexate or ondansetron
2) Known allergy to methotrexate or ondansetron
3) Known congenital Long-QT syndrome
4) Taking the medication apomorphine
5) Family unable to complete questionnaires in English or French
Participate
Additional information
Contact information
Please contact Dwaraka Veeramreddy, if you are interested in participation in the study.
Principal investigator:
Heinrike Schmeling
Clinical trial:
Yes
REB-ID:
REB19-1339