The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis (OPT-JIA)
Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Arthritis, Arthritis, Juvenile, Joint Diseases, Rheumatic diseases, Pragmatic Trials, Ondansetron, Methotrexate, Nausea
Eligibility Criteria
Inclusion Criteria:
- Ages 4-16 years
- Diagnosis of JIA as per ILAR criteria [1], irrespective of JIA category
- Followed at a CAPRI centre in Canada
- Starting methotrexate to control JIA manifestations (arthritis, uveitis, psoriasis). (Female subjects of child bearing potential who are taking methotrexate for JIA cannot be pregnant, breastfeeding, or planning a pregnancy while on the drug and females of childbearing potential who are sexually active must use highly effective medically acceptable contraception. Subjects who stop methotrexate during the study will also discontinue ondansetron.)
- Informed written consent to participate
- Participating in the CAPRI JIA Registry
Exclusion Criteria:
- Previous use of methotrexate
- Known hypersensitivity to ondansetron or any components of its formulations
- Known hypersensitivity to other 5-HT3 antagonists
- Known congenital Long-QT syndrome
- Patients taking other medicinal products that lead to either QT prolongation or electrolyte abnormalities
Because the serotonin syndrome may occur when ondansetron is combined with other agents that may affect the serotonergic neurotransmitter system, patients receiving any of the serotonergic and/or neuroleptic drugs listed below will be excluded:
• Triptans, SSRIs, SNRIs, lithium, sibutramine, fentanyl and its analogues, dextromethorphan, tramadol, tapendalol, meperidine, methadone, pentazocine or St. John's Wort (Hypericum perforatum), MAOIs, linezolid, methylene blue.
- Patients who are pregnant or breastfeeding, or are sexually active and unwilling to practice an acceptable method of birth control.
- Family unable to complete questionnaires in English or French
Sites / Locations
- University of Calgary / Alberta Children's HospitalRecruiting
- University of Alberta
- BC Children's HospitalRecruiting
- University of Manitoba/Children's hospital research institute
- Memorial University/Janeway Childrens Health and Rehabilitation Centre
- IWK Health Centre
- McMaster University/McMaster Children's HospitalRecruiting
- London Health Sciences CentreRecruiting
- Hospital for Sick ChildrenRecruiting
- McGill University Health CentreRecruiting
- Université de MontréalRecruiting
- CHU de Quebec - Universite LavalRecruiting
- University of Sherbrooke
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ondansetron premedication
Ondansetron as needed
Methotrexate and folic/folinic acid as prescribed by physician. Ondansetron: 2 mg if <15Kg, 4 mg if 15-30Kg, 8 mg if >30Kg to be taken by mouth one hour before each weekly methotrexate dose, followed by two additional doses every 6-8 hours if awake. To be started from the very first dose of methotrexate.
Methotrexate and folic/folinic acid as prescribed by physician. ONLY children who report nausea/vomiting during regular care will be prescribed ondansetron at the same dose as in experimental group (2 mg if <15Kg, 4 mg if 15-30Kg, 8 mg if >30Kg to be taken by mouth one hour before each weekly methotrexate dose, followed by two additional doses every 6-8 hours if awake), as per the attending rheumatologist's discretion