The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT04169828
• Date of registration: 18/11/2019
• Prospective Registration: No
• Primary sponsor: University of British Columbia
• Public title: The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis OPT-JIA
• Scientific title: The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis
• Date of first enrolment: August 2, 2019
• Target sample size: 52
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04169828
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jaime Guzman, MD, FRCPC
• Affiliation: University of British Columbia

Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Ondansetron

Drug: Folic/folinic acid

Drug: Methotrexate

Primary Outcome(s)

Proportion of subjects that remain on methotrexate with no intolerance [Time Frame: One year after starting methotrexate.]

Secondary Outcome(s)

MISS questionnaire [Time Frame: 4-8 months after starting methotrexate]

Quality of My Life scale [Time Frame: 4-8 months after starting methotrexate]

Methotrexate intolerance [Time Frame: Within one year]

Starting a biologic medication [Time Frame: Within one year]

Attainment of inactive disease [Time Frame: Within one year]

Frequency and cumulative incidence of adverse events (safety and tolerability) [Time Frame: Within one year]

Secondary ID(s)

H18-03176

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Calgary

London Health Sciences Centre

Alberta Children's Hospital

University of Manitoba

McMaster Children's Hospital

The Arthritis Society, Canada

McMaster University

The Hospital for Sick Children

Université de Montréal

McGill University Health Centre/Research Institute of the McGill University Health Centre