The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

DRUG

Methotrexate

Children in both the intervention and control group will receive Methotrexate dosed as prescribed by the attending rheumatologist

DRUG

Ondansetron

Children in the intervention group will be prescribed premedication with oral ondansetron. Children in the control group will be prescribed ondansetron ONLY if the child reports nausea/vomiting during regular treatment care with Methotrexate

DRUG

Folic/folinic acid

Children in both intervention and control group will receive folic acid or folinic acid dosed as prescribed by the attending rheumatologist.

Sponsors & Collaborators

• The Arthritis Society, Canada

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

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

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• Alberta Children's Hospital

  collaborator OTHER

• McMaster University

  collaborator OTHER

• McMaster Children's Hospital

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• Jaime Guzman, MD, FRCPC · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-02

Primary Completion

2025-01-17

Completion

2025-01-17

Countries

• Canada

Study Locations