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The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis (OPT-JIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169828
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
The Arthritis Society, Canada
University of Calgary
IWK Health Centre
The Hospital for Sick Children
McGill University Health Centre/Research Institute of the McGill University Health Centre
London Health Sciences Centre
University of Manitoba
Children's Hospital of Eastern Ontario
Alberta Children's Hospital
McMaster University
McMaster Children's Hospital
Université de Montréal
Royal University Hospital Foundation
Memorial University of Newfoundland
Information provided by (Responsible Party):
Jaime Guzman, University of British Columbia

Brief 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, we hope to give kids and families a better quality of life and see a more cost-effective use of medication.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Methotrexate Drug: Ondansetron Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic RCTs use alternative designs to establish effectiveness of a treatment strategy in usual care. Pragmatic trials aim to include all subjects in whom the treatment may be used and are conducted under the usual conditions of practice to demonstrate effectiveness under real word circumstances. Patients enrolled in a pragmatic trial are more representative because eligibility criteria are less strict.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022


Arm Intervention/treatment
Experimental: Ondansetron premedication
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.
Drug: Methotrexate
Children in both the intervention and control group will receive Methotrexate dose as prescribed by the rheumatologist
Other Name: Trexall

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

Other Name: Zofran

Active Comparator: Ondansetron as needed
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
Drug: Methotrexate
Children in both the intervention and control group will receive Methotrexate dose as prescribed by the rheumatologist
Other Name: Trexall

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

Other Name: Zofran




Primary Outcome Measures :
  1. Proportion of subjects that remain on methotrexate with no intolerance [ Time Frame: One year after starting methotrexate. ]
    Intolerance will be defined as ≥6 points in the English or French versions of the validated Methotrexate Intolerance Severity Score, MISS [10, 36]. The MISS questionnaire takes less than 2 minutes to complete (see Appendix). It will be added to the Registry questionnaires completed by families online or on paper as per the CAPRI Centre usual Registry procedures.


Secondary Outcome Measures :
  1. Methotrexate intolerance [ Time Frame: Within one year ]
    The cumulative incidence of methotrexate intolerance

  2. Attainment of inactive disease [ Time Frame: Within one year ]
    The cumulative incidence of attainment of inactive disease, defined by Wallace criteria

  3. Starting a biologic medication [ Time Frame: Within one year ]
    The cumulative incidence of starting a biologic medication

  4. Quality of My Life scale [ Time Frame: 4-8 months after starting methotrexate ]
    Mean quality of life scores in the Quality of My Life scale

  5. MISS questionnaire [ Time Frame: 4-8 months after starting methotrexate ]
    Mean scores in the MISS questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 4-16 years
  2. Diagnosis of JIA as per ILAR criteria, irrespective of JIA category
  3. Followed at a CAPRI centre in Canada
  4. Starting methotrexate to control JIA manifestations (arthritis, uveitis, psoriasis)
  5. Informed written consent to participate

Exclusion Criteria:

  1. Previous use of methotrexate
  2. Known allergy to ondansetron
  3. Known congenital Long-QT syndrome
  4. Family unable to complete questionnaires in English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169828


Contacts
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Contact: Jaime Guzman, MD, FRCPC 604-875-2437 jguzman@cw.bc.ca
Contact: Felice Mizan 6048752000 ext 4839 felice.mizan@cw.bc.ca

Locations
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Canada, Alberta
University of Calgary / Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada
Contact: Heinrike Schmeling, MD         
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada
Contact: Dax Rumsey, MD         
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Jaime Guzman, MD, FRCPC         
Canada, Manitoba
University of Manitoba/Children's hospital research institute Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Kerstin Gerhold, MD, MSc         
Canada, Newfoundland and Labrador
Memorial University/Janeway Childrens Health and Rehabilitation Centre Not yet recruiting
St. John's, Newfoundland and Labrador, Canada
Contact: Paul Dancey, MD, FRCPC         
Canada, Nova Scotia
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Adam Huber, MD         
Canada, Ontario
McMaster University/McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada
Contact: Michelle Batthish, MD, FRCPC         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: Roberta Berard, MD         
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada
Contact: Ciaran Duffy, MD         
Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada
Contact: Brian Feldman, MD, MSc         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada
Contact: Gaëlle Chédeville, MD         
Université de Montréal Not yet recruiting
Montréal, Quebec, Canada
Contact: Julie Barsalou, MD         
University of Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada
Contact: Alessandra Bruns, MD         
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada
Contact: Alan Rosenberg, MD         
Sponsors and Collaborators
University of British Columbia
The Arthritis Society, Canada
University of Calgary
IWK Health Centre
The Hospital for Sick Children
McGill University Health Centre/Research Institute of the McGill University Health Centre
London Health Sciences Centre
University of Manitoba
Children's Hospital of Eastern Ontario
Alberta Children's Hospital
McMaster University
McMaster Children's Hospital
Université de Montréal
Royal University Hospital Foundation
Memorial University of Newfoundland
Investigators
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Principal Investigator: Jaime Guzman, MD, FRCPC University of British Columbia
Additional Information:
Publications:

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Responsible Party: Jaime Guzman, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04169828    
Other Study ID Numbers: H18-03176
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If the ethics boards at all participating centres approve individual participant data sharing we will upload to clinicaltrials.gob a data sharing plan at that time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaime Guzman, University of British Columbia:
Arthritis
Arthritis, Juvenile
Joint Diseases
Rheumatic diseases
Pragmatic Trials
Ondansetron
Methotrexate
Nausea
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Ondansetron
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics