Ondansetron Premedication for Juvenile Idiopathic Arthritis

(OPT-JIA Trial)

No longer recruiting at 13 trial locations

Overseen By Angelyne Rivera

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Methotrexate

Must not be taking: SSRIs, SNRIs, Triptans, others

Disqualifiers: Previous methotrexate, Long-QT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking Ondansetron (Zofran) before methotrexate can reduce nausea and vomiting in children with Juvenile Idiopathic Arthritis (JIA). Methotrexate controls symptoms like joint swelling, but its side effects can be challenging, leading to more costly treatments. By adding Ondansetron, researchers hope more children can continue methotrexate and enhance their quality of life. This trial targets children aged 4 to 16 who are newly starting methotrexate for JIA. As an unphased trial, it offers participants a unique opportunity to potentially improve their treatment experience and contribute to valuable research.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications if they interact with ondansetron, like those affecting serotonin levels or causing heart rhythm issues. The trial does not specify stopping all current medications, but you should discuss your specific situation with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ondansetron is generally well-tolerated and often used to prevent nausea and vomiting. Some studies found that taking ondansetron for several days can slow colon function, but it does not alter certain hormone levels in the blood.

Regarding side effects, ondansetron does not significantly affect hormone balance, which is reassuring. This medication has FDA approval for other uses, indicating its safety. Overall, ondansetron is generally considered safe for children, especially for managing nausea caused by medications like methotrexate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ondansetron as a premedication for juvenile idiopathic arthritis because it addresses a common side effect of methotrexate treatment: nausea and vomiting. Unlike the standard approach, where ondansetron is given only if nausea occurs, this method proactively prevents discomfort by administering ondansetron before methotrexate. This strategy could improve patient comfort and adherence to treatment, making it a promising option for enhancing the quality of life for young patients.

What evidence suggests that Ondansetron premedication could be effective for reducing nausea in Juvenile Idiopathic Arthritis?

Research shows that ondansetron, a medicine that prevents nausea, can reduce nausea and vomiting in children taking methotrexate for juvenile idiopathic arthritis (JIA). In this trial, some participants will receive ondansetron as premedication before their methotrexate doses, while others will receive it only as needed if they experience nausea or vomiting. Early results suggest that children who take ondansetron before their methotrexate have fewer stomach issues. This may allow them to continue using methotrexate longer without needing more costly treatments. Ondansetron blocks signals in the brain that cause nausea, making it easier for kids to take their medicine. Overall, it seems promising for improving the quality of life for children with JIA. ^{1 3 5 6 7}

Who Is on the Research Team?

Jaime Guzman, MD, FRCPC

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Followed at a CAPRI centre in Canada

I am between 4 and 16 years old.

I have been diagnosed with juvenile idiopathic arthritis.

Exclusion Criteria

Known hypersensitivity to ondansetron or any components of its formulations

My family cannot fill out forms in English or French.

Known hypersensitivity to other 5-HT3 antagonists

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methotrexate with ondansetron premedication or ondansetron as needed for one year

52 weeks

Weekly administration of methotrexate

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Folic/folinic acid
• Methotrexate
• Ondansetron

Trial Overview 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.

How Is the Trial Designed?

Group I: Ondansetron premedication Experimental Treatment 3 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 needed Active Control 3 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

Methotrexate is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Trexall for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis

Approved in Canada as Mexate for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis

Approved in European Union as Methotrexate for:

• Acute lymphoblastic leukemia
• Non-Hodgkin's lymphoma
• Osteosarcoma
• Breast cancer
• Lung cancer
• Head and neck cancer
• Psoriasis
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Royal University Hospital Foundation

Collaborator

Trials

23

Recruited

7,900+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

McMaster Children's Hospital

Collaborator

Trials

43

Recruited

19,900+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Alberta Children's Hospital

Collaborator

Trials

58

Recruited

44,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8698848/

Spectrum of Clinical Research in Juvenile Idiopathic Arthritis A total of 9/72 studies (12.5%) were related to medications other than DMARD and all of them of the interventional type, concerning the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04169828

The Ondansetron Premedication Trial in Juvenile ... To evaluate if routine pre-medication with the anti-emetic ondansetron reduces methotrexate intolerance and increases the proportion of children with JIA able ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04169828/the-ondansetron-premedication-trial-in-juvenile-idiopathic-arthritis

The Ondansetron Premedication Trial in Juvenile ... This registry-based pragmatic randomized controlled trial will evaluate if routine premedication with the anti-emetic drug Ondansetron, reduces ...

4. acrabstracts.org acrabstracts.org/abstract/preliminary-results-of-the-ondansetron-pre-medication-trial-in-juvenile-idiopathic-arthritis-a-pragmatic-randomized-controlled-trial-nested-in-the-capri-registry/

Preliminary Results of the Ondansetron Pre-medication ... Our aim was to evaluate if routine premedication with the anti-emetic ondansetron reduces MTX intolerance and increases the proportion of children able to ...

5. experts.mcmaster.ca experts.mcmaster.ca/scholarly-works/3511641

Preliminary Results of the Ondansetron Pre-medication Trial ... Preliminary Results of the Ondansetron Pre-medication Trial in Juvenile Idiopathic Arthritis: A Pragmatic Randomized Controlled Trial Nested in the CAPRI ...

6. go.drugbank.com go.drugbank.com/drugs/DB00904

Ondansetron: Uses, Interactions, Mechanism of Action Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. Ondansetron has no effect on plasma prolactin concentrations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9002113/

Application of Intra-articular Corticosteroid Injection in ... Studies have shown that IACIs apply to any subcategory of juvenile idiopathic arthritis (JIA), especially to JIA with few joints.