The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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, the investigators hope to give kids and families a better quality of life and see a more cost-effective use of medication.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Alberta Children's Hospital; Children's Hospital of Eastern Ontario; IWK Health Centre; London Health Sciences Centre; McGill University Health Centre/Research Institute of the McGill University Health Centre; McMaster Children's Hospital; McMaster University; Memorial University of Newfoundland; Royal University Hospital Foundation; The Arthritis Society, Canada; The Hospital for Sick Children; Université de Montréal; University of Calgary; University of Manitoba
• Treatments: Folic Acid; Leucovorin; Levoleucovorin; Methotrexate; Ondansetron

Criteria

Inclusion Criteria:

1. Ages 4-16 years

2. Diagnosis of JIA as per ILAR criteria [1], irrespective of JIA category

3. Followed at a CAPRI centre in Canada

4. 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.)

5. Informed written consent to participate

6. Participating in the CAPRI JIA Registry

Exclusion Criteria:

1. Previous use of methotrexate

2. Known hypersensitivity to ondansetron or any components of its formulations

3. Known hypersensitivity to other 5-HT3 antagonists

4. Known congenital Long-QT syndrome

5. Patients taking other medicinal products that lead to either QT prolongation or electrolyte abnormalities

6. 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.

7. Patients who are pregnant or breastfeeding, or are sexually active and unwilling to practice an acceptable method of birth control.

8. Family unable to complete questionnaires in English or French