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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-8 months after starting methotrexate
Awards & highlights

OPT-JIA Trial 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.Check my eligibility
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.See study design
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.

OPT-JIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 4 and 16 years old.
Select...
I have been diagnosed with juvenile idiopathic arthritis.

OPT-JIA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects that remain on methotrexate with no intolerance
Secondary outcome measures
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
14%
Rheumatoid arthritis
12%
Bronchitis
9%
Nasopharyngitis
9%
Rhinitis
7%
Asthenia
7%
Alanine aminotransferase increased
7%
Headache
6%
Back pain
6%
Ear infection
6%
Urinary tract infection
6%
Neutropenia
6%
Arthralgia
6%
Diarrhoea
5%
Injection site erythema
4%
Insomnia
4%
Pruritus
4%
Abdominal pain
4%
Nausea
4%
Transaminases increased
4%
Hypertension
4%
Hepatocellular injury
3%
Psoriasis
2%
Neck pain
1%
Deep vein thrombosis
1%
Cervical dysplasia
1%
Dyspepsia
1%
Gastric volvulus
1%
Intestinal ischaemia
1%
Vomiting
1%
Pulmonary embolism
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Myocardial infarction
1%
Cataract
1%
Angioedema
1%
Disseminated tuberculosis
1%
Septic shock
1%
Fall
1%
Nephrolithiasis
1%
Lung disorder
1%
Gastric ulcer
1%
Meningitis tuberculous
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ - All Participants
TCZ COMBO - All Participants
TCZ MONO - All Participants

OPT-JIA 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
Folic/folinic acid
2013
Completed Phase 2
~170
Ondansetron
2011
Completed Phase 4
~4010
Methotrexate
2013
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

McMaster UniversityOTHER
877 Previous Clinical Trials
2,596,008 Total Patients Enrolled
Royal University Hospital FoundationOTHER
22 Previous Clinical Trials
7,496 Total Patients Enrolled
Université de MontréalOTHER
211 Previous Clinical Trials
102,232 Total Patients Enrolled

Media Library

Methotrexate (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04169828 — N/A
Juvenile Idiopathic Arthritis Research Study Groups: Ondansetron as needed, Ondansetron premedication
Juvenile Idiopathic Arthritis Clinical Trial 2023: Methotrexate Highlights & Side Effects. Trial Name: NCT04169828 — N/A
Methotrexate (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169828 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathological conditions does Methotrexate commonly address?

"Methotrexate is a viable therapeutic option for managing multiple sclerosis, pharmacotherapy regimens, and advance directives."

Answered by AI

Are there any eligibility criteria I must satisfy to join this research program?

"The current clinical trial is enrolling 176 minors aged 4-16 with juvenile arthritis. To be eligible, they must commence methotrexate treatment and provide written consent to participate in the CAPRI JIA Registry. Additionally, female participants of child bearing potential who are taking methotrexate must practice highly effective contraception or abstain from sexual activity while on the drug."

Answered by AI

Are there multiple locales in the United States where this research is taking place?

"This experiment is being conducted by 14 sites, with some of these located in Montréal, London, and Ottawa. For the comfort of participants it is recommended to pick a medical centre closest to home for ease of travel requirements when enrolling."

Answered by AI

What is the current quota for participants in this research experiment?

"Indeed, the information on clinicaltrials.gov corroborates that this experiment is actively searching for research participants. This trial was initially posted on August 2nd 2019 and has been recently updated on October 29th 2021. The study requires 176 candidates to be recruited from 14 distinct locations."

Answered by AI

Does this experimental research include mature adults?

"As per the accepted criteria, only patients aged 4 to 16 can be admitted into this medical trial."

Answered by AI

Are any new participants being enrolled in this trial currently?

"Affirmative. According to clinicaltrials.gov, this medical experiment which was initially reported on August 2nd 2019 is currently enrolling participants. A total of 176 volunteers are needed across 14 sites."

Answered by AI

Are there any other investigations into the use of Methotrexate?

"Presently, 478 clinical trials are assessing the utility of methotrexate. Of those in progress, 141 have entered Phase 3. While much of this research is conducted at Woolloongabba, Queensland, there are 20336 sites running their own respective studies on Methotrexate worldwide."

Answered by AI
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~5 spots leftby Oct 2024