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Antimetabolite

Ondansetron Premedication for Juvenile Idiopathic Arthritis (OPT-JIA Trial)

N/A

Waitlist Available

Led By Jaime Guzman, MD, FRCPC

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 4-16 years

Diagnosis of JIA as per ILAR criteria, irrespective of JIA category

Must not have

Family unable to complete questionnaires in English or French

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-8 months after starting methotrexate

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if pre-medicating with Ondansetron reduces nausea and vomiting in children taking methotrexate for Juvenile Arthritis.

Who is the study for?

This trial is for kids aged 4-16 with Juvenile Idiopathic Arthritis (JIA) in Canada, who are starting methotrexate treatment. They must not be pregnant or planning pregnancy and agree to use contraception if applicable. Kids with certain heart conditions, on specific medications like SSRIs or MAOIs, or allergic to Ondansetron can't join.

What is being tested?

The study tests whether taking Ondansetron before methotrexate reduces nausea and vomiting in children with JIA. It's a randomized controlled trial comparing the effects of premedication against usual care without it, aiming to improve life quality and medication cost-effectiveness.

What are the potential side effects?

Ondansetron may cause headaches, constipation or diarrhea, fatigue, and sometimes serious side effects like changes in heartbeat rhythm. Methotrexate can lead to nausea (which this trial aims to prevent), mouth sores, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 16 years old.

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I have been diagnosed with juvenile idiopathic arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My family cannot fill out forms in English or French.

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I am taking medication that affects my heart rhythm or electrolyte levels.

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I am currently taking medication that affects my serotonin levels.

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I have been diagnosed with Long-QT syndrome.

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I have previously used methotrexate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-8 months after starting methotrexate

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-8 months after starting methotrexate

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-8 months after starting methotrexate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects that remain on methotrexate with no intolerance

Secondary study objectives

Attainment of inactive disease

Frequency and cumulative incidence of adverse events (safety and tolerability)

MISS questionnaire

+3 more

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987

11%

Rheumatoid arthritis

11%

Rhinitis

Asthenia

Bronchitis

Nasopharyngitis

Alanine aminotransferase increased

Arthralgia

Headache

Neutropenia

Diarrhoea

Back pain

Hepatocellular injury

Transaminases increased

Insomnia

Abdominal pain

Urinary tract infection

Ear infection

Injection site erythema

Pruritus

Nausea

Hypertension

Gastric volvulus

Angioedema

Gastric ulcer

Intestinal ischaemia

Pulmonary embolism

Deep vein thrombosis

Hypertensive crisis

Iron deficiency anaemia

Cataract

Cervical dysplasia

Disseminated tuberculosis

Septic shock

Meningitis tuberculous

Fall

100%

80%

60%

40%

20%

Study treatment Arm

TCZ COMBO - All Participants

TCZ MONO - All Participants

TCZ - All Participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ondansetron premedicationExperimental Treatment3 Interventions

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.

Group II: Ondansetron as neededActive Control3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2019

Completed Phase 4

~4400

Folic/folinic acid

2013

Completed Phase 2

~170