Ondansetron Premedication for Juvenile Idiopathic Arthritis

(OPT-JIA Trial)

Recruiting at 11 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

52 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jaime Guzman, MD, FRCPC

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+