UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease

Last updated: August 16, 2024
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus

Arthritis And Arthritic Pain

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT06560606
1771
  • Ages < 18
  • All Genders

Study Summary

Childhood arthritis is a chronic disabling disease. New medications called biologic therapies are now available to treat arthritis that target key biologic molecules that cause inflammation. Biologic therapies, while very effective in treating arthritis in children, may have serious side effects including infections and potentially cancers, and are very expensive and doctors don't know, which one to choose for which child. The investigators will develop tests that enable them to learn about the biology of each child's arthritis and be able to predict when and which biologic therapy to start and when to stop.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Cohort 1: - Biologic Basis of JIA

  • ≤18 years*

  • Active objective arthritis suspected to be JIA or diagnosed with JIA within 6 monthsof enrolment

  • Treatment naïve except for NSAIDs, allowed to have received NSAIDS within 6 monthsof diagnosis

Cohort 2 - Start Biologics

  • JIA diagnosis as per ILAR criteria (all subtypes)

  • ≤18 years*

  • Active arthritis

  • For sJIA, active disease not necessarily with arthritis.

  • Time of start, restart or switch biologic therapy: e.g. failure,insufficient/partial response or intolerance

Cohort 3 - Stop Biologics

  • JIA diagnosis as per ILAR criteria (all subtypes)

  • ≤18 years*

  • Inactive disease

  • Discontinuing/tapering biologics for inactive disease

Cohort 4: Extreme Phenotypes

  • Unexplained systemic inflammation with arthritis/arthralgia as a part ofmanifestations

  • High suspicion of genetic contribution

  • Severely affected patients with difficult to control disease (ie failure of multiplebiologics)

Exclusion

Exclusion Criteria:

Cohort 1 :

  • Arthritis explained by another diagnosis

  • Joint injections as previous treatment less than 4 weeks prior to enrollment

Cohort 2:

  • Arthritis explained by any other cause

  • Start on biologics as an indication for uveitis only

Cohort 3:

  • Tapering scheme > 12 months to complete biologics stop

Cohort 4:

  • Arthritis explained by another diagnosis

Study Design

Total Participants: 4100
Study Start date:
August 24, 2018
Estimated Completion Date:
March 30, 2027

Study Description

UCAN CAN-DU is a multicenter observational cohort study that will collect prospective data from children with arthritis. Biologic samples, clinical data and patient reported outcomes will be collected.

In addition, the study will also include a health economics component which will include a number of complementary approaches for quantifying and comparing benefits and risks that promote evidence-based, patient centered health care. This will address both the personal and societal economic burden of disease and include qualitative methods to inform the measurement of preferences, economic and simulation modelling to assess the value of biomarker testing. The socioeconomic impact of biomarker based treatment will be evaluated.

All clinical, biological and patient-derived data will be collected at an aggregation point housed and managed by High Performance Computing 4 Health (HPC4Health), a private hospital-only secure cloud-computing service within Compute Canada and physically located at SickKids/UHN. These databases and apps include biospecimen data and data collected through the eHealth platform. This will enable the study team to share and integrate data in near real-time into analytic models throughout the study course; hence providing a near real-time feedback from bench to bedside and vice versa.

The analysis of the cohorts will help define and confirm the biologic pathways predictive of disease course, treatment response and disease remission. This knowledge will then be used to develop a comprehensive clinical predictive tool to guide effective and safe treatment of childhood arthritis.

Connect with a study center

  • Alberta Children's Hospital - University of Calgary

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • BC Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • Children's Hospital Health Science Centre Winnipeg

    Winnipeg, Manitoba R3A 1R9
    Canada

    Active - Recruiting

  • Janeway Children's Hospital and Rehabilitation Centre

    St John's, Newfoundland and Labrador A1B 3V6
    Canada

    Active - Recruiting

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Active - Recruiting

  • McMaster Children's Hospital

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • Children's Hospital, London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1E8
    Canada

    Active - Recruiting

  • Montréal Children's Hospital

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 5A2
    Canada

    Active - Recruiting

  • Amalia Children's Hospital, Radboudumc

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Sint Maartenskinderkliniek

    Boxmeer, North Brabant 6574 NA
    Netherlands

    Active - Recruiting

  • Emma Children's Hospital, Amsterdam UMC

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Willem-Alexander Children's Hospital, LUMC

    Leiden, South Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Sophia Children's Hospital, EMC

    Rotterdam, South Holland 3015 CN
    Netherlands

    Active - Recruiting

  • Beatrix Children's Hospital, UMCG

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Wilhelmina Children's Hospital, UMCU

    Utrecht, 3584 EA
    Netherlands

    Active - Recruiting

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