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

August 16, 2024 updated by: Rae Yeung, The Hospital for Sick Children
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital - University of Calgary
        • Sub-Investigator:
          • Nicole Johnson, MD
        • Sub-Investigator:
          • Rebeka Stevenson, MD
        • Principal Investigator:
          • Paivi Miettunen, MD
        • Sub-Investigator:
          • Muhammed Dhalla, MD
        • Sub-Investigator:
          • Heinrike Schmeling, MD
        • Sub-Investigator:
          • Marinka Twilt, MD
        • Sub-Investigator:
          • Susanne Benseler, MD
        • Sub-Investigator:
          • Deborah Marshall, PhD
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital
        • Principal Investigator:
          • Dax G Rumsey, MD, MSc, FRCP(C)
        • Sub-Investigator:
          • Daniah Basodan, MBBS, FRCP(C)
        • Sub-Investigator:
          • Lillian Lim, MD, MPH, FRCP(C)
        • Sub-Investigator:
          • Tara McGrath, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • BC Children's Hospital
        • Principal Investigator:
          • Lori Tucker, MD, FRCPC
        • Sub-Investigator:
          • Andrea Human, MD, MScHQ, FRCPC
        • Sub-Investigator:
          • David Cabral, MBBS, FRCPC
        • Sub-Investigator:
          • Jaime Guzman, MD, MSc, FRCPC
        • Sub-Investigator:
          • Kim Morishita, MD, MHSc, FRCPC
        • Sub-Investigator:
          • Kristin Houghton, MD, MSc, FRCPC, Dip Sports Med
        • Sub-Investigator:
          • Herman Tam, MD, FRCPC
        • Sub-Investigator:
          • Mercedes Chan, MBBS, MHPE, FRCPC
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • Children's Hospital Health Science Centre Winnipeg
        • Principal Investigator:
          • Lily Lim, MBBS, MRCPCH, FRCPC, PhD
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Janeway Children's Hospital and Rehabilitation Centre
        • Principal Investigator:
          • Paul Dancey, MD, FRCPC
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • IWK Health Centre
        • Principal Investigator:
          • Adam Huber, MD
        • Sub-Investigator:
          • Elizabeth Stringer, MD
        • Sub-Investigator:
          • Chelsea DeCoste, MD
        • Sub-Investigator:
          • Bianca Lang, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster Children's Hospital
        • Principal Investigator:
          • Michelle Batthish, MD
        • Sub-Investigator:
          • Tania Cellucci
        • Sub-Investigator:
          • Liane Heale
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital, London Health Sciences Centre
        • Principal Investigator:
          • Roberta Berard, MD
        • Sub-Investigator:
          • Jonathan Park, MD
        • Sub-Investigator:
          • Erkan Demirkaya, MD
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Sub-Investigator:
          • Tala El Tal, MD
        • Contact:
        • Principal Investigator:
          • Ciaran Duffy, MB
        • Sub-Investigator:
          • Roman Jurencak, MD
        • Sub-Investigator:
          • Nadia Luca, MD
      • Toronto, Ontario, Canada, M5G 1E8
        • Recruiting
        • The Hospital for Sick Children
        • Sub-Investigator:
          • Ronald Laxer, MDCM
        • Sub-Investigator:
          • Elizaveta Limenis, MD
        • Sub-Investigator:
          • Lynn Spiegel, MD
        • Sub-Investigator:
          • Ruud Verstegen, MD
        • Sub-Investigator:
          • Dilan Dissanayake, MD
        • Principal Investigator:
          • Shirley Tse, MD
        • Principal Investigator:
          • Deborah Levy, MD
        • Sub-Investigator:
          • Brian Feldman, MD
        • Sub-Investigator:
          • Evelyn Rozenblyum, MD
        • Sub-Investigator:
          • Jennifer JY Lee, MD
        • Sub-Investigator:
          • Alisa Rachlis, MD
        • Sub-Investigator:
          • Rae Yeung, MD
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Montreal Children's Hospital
        • Principal Investigator:
          • Claire LeBlanc, M.A, MD, FRCPC, Dip Sport Med
        • Sub-Investigator:
          • Gaelle Chedeville, MsC, MD
        • Sub-Investigator:
          • Rosie Scuccimarri, MD
        • Sub-Investigator:
          • Sarah Campillo, MD, FRCPC
        • Sub-Investigator:
          • Piya Lahiry, M.SC, PHD, MD, FRCPC
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5A2
        • Recruiting
        • University of Saskatchewan
        • Principal Investigator:
          • Alan Rosenberg
        • Sub-Investigator:
          • Mehul Jariwala
        • Sub-Investigator:
          • Tristan Kerr
        • Sub-Investigator:
          • Kate Neufeld
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Beatrix Children's Hospital, UMCG
        • Sub-Investigator:
          • Elisabeth Legger, MD
        • Principal Investigator:
          • Wineke Armbrust, MD, PhD
      • Utrecht, Netherlands, 3584 EA
        • Recruiting
        • Wilhelmina Children's Hospital, UMCU
        • Contact:
        • Sub-Investigator:
          • Annet van Royen-Kerkhof, MD, PhD
        • Principal Investigator:
          • Bas Vastert, MD, PhD
        • Sub-Investigator:
          • Berent Prakken, MD, PhD
        • Sub-Investigator:
          • Erika VanNieuwenhove, MD, PhD
        • Principal Investigator:
          • Joost Swart, MD, PhD
        • Sub-Investigator:
          • Marc Jansen, MD, PhD
        • Sub-Investigator:
          • Nico Wulffraat, MD, PhD
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Amalia Children's Hospital, Radboudumc
        • Principal Investigator:
          • Ellen Schatorjé, MD, PhD
        • Sub-Investigator:
          • Esther Hoppenreijs, MD
    • North Brabant
      • Boxmeer, North Brabant, Netherlands, 6574 NA
        • Recruiting
        • Sint Maartenskinderkliniek
        • Sub-Investigator:
          • Ellen Schatorjé, MD, PhD
        • Principal Investigator:
          • Esther Hoppenreijs, MD
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Emma Children's Hospital, Amsterdam UMC
        • Sub-Investigator:
          • Dieneke Schonenberg, MD, PhD
        • Sub-Investigator:
          • Mariken Gruppen, MD
        • Principal Investigator:
          • Merlijn van den Berg, MD, PhD
        • Sub-Investigator:
          • Giske Biesbroek, MD
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Willem-Alexander Children's Hospital, LUMC
        • Sub-Investigator:
          • Danielle Brinkman, MD
        • Principal Investigator:
          • Petra Hissink Muller, MD
      • Rotterdam, South Holland, Netherlands, 3015 CN
        • Recruiting
        • Sophia Children's Hospital, EMC
        • Sub-Investigator:
          • Philomine van Pelt, MD, PhD
        • Sub-Investigator:
          • Marleen Verkaaik, MD
        • Principal Investigator:
          • Sylvia Kamphuis, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the patient population of a UCAN study site.

Description

Inclusion Criteria:

Cohort 1: - Biologic Basis of JIA

  • ≤18 years*
  • Active objective arthritis suspected to be JIA or diagnosed with JIA within 6 months of enrolment
  • Treatment naïve except for NSAIDs, allowed to have received NSAIDS within 6 months of 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 of manifestations
  • High suspicion of genetic contribution
  • Severely affected patients with difficult to control disease (ie failure of multiple biologics)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1 - Biologic Basis of JIA

The objectives for this group are to help researchers look at childhood arthritis and determine which management approach is best for each individual child.

To be eligible for this group:

Participant must be ≤ 18 years of age at time of study enrollment. Participant is suspected to have JIA. Participant has not received any treatment other than non-steroidal anti-inflammatory drugs, such as acetaminophen.
Cohort 2 - Start Biologics

The objectives for this group are to help researchers develop a tool to predict response to therapy.

To be eligible for this group:

Participant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is active. Participant will be starting, re-starting or switching to a new biologic therapy.
Cohort 3 - Stop Biologics

The objectives for this group are to help researchers develop a tool to predict who will remain in remission after discontinuing therapy.

To be eligible for this group:

Participant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is inactive. Participant will be stopping or tapering biologic therapy.
Cohort 4: Extreme Phenotypes

The objective for this group is new gene discovery and drug target identification.

To be eligible for this group:

There is high suspicion of genetic contribution. Participants are severely affected with difficult to control arthritis or systemic disease.

There is unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prospectively collect essential clinical data elements from children with new onset JIA
Time Frame: Up to 24 months
Up to 24 months
Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA
Time Frame: Up to 24 months
Up to 24 months
Evaluate clinical outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Time Frame: Up to 24 months
Up to 24 months
Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA.
Time Frame: Up to 12 months
Up to 12 months
Prospectively collect essential biological data elements from children with new onset JIA
Time Frame: Up to 24 months
Up to 24 months
Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA
Time Frame: Up to 24 months
Up to 24 months
Evaluate biological outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Time Frame: Up to 24 months
Up to 24 months
Prospectively collect essential biological data elements from children with extreme phenotypes of JIA
Time Frame: Up to 12 months
Up to 12 months
Prospectively collect essential socioeconomic data elements from children with new onset JIA
Time Frame: Up to 12 months
Up to 12 months
Evaluate the socioeconomic impact associated with the use of therapeutic agents in children with JIA
Time Frame: Up to 12 months
Up to 12 months
Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA
Time Frame: Up to 24 months
Up to 24 months
Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
ZonMw: The Netherlands Organisation for Health Research and Development
The Arthritis Society, Canada
Genome Canada
Genome Alberta
ReumaNederland
Ontario Genomics

Investigators

  • Principal Investigator: Rae SM Yeung, MD, PhD, FRCPC, The Hospital for Sick Children (SickKids), University of Toronto
  • Principal Investigator: Nico Wulffraat, MD, PhD, Wilhelmina Children's Hospital, University Medical Center Utrecht
  • Principal Investigator: Susa Benseler, MD, PhD, Alberta Children's Hospital and Cumming School of Medicine, University of Calgary
  • Principal Investigator: Joost Swart, MD, PhD, Wilhelmina Children's Hospital, University Medical Center Utrecht
  • Principal Investigator: Bas Vastert, MD, PhD, Wilhelmina Children's Hospital, University Medical Center Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data Access Advisory Committee (DAAC) has been formed. The DAAC is an advisory body tasked with guiding, developing and implementing principals for data sharing and policy for data access, including development of subcommittees to be formed to review request for secondary analysis or secondary or ancillary projects. The DAAC reports to the Executive Committee.

IPD will only be shared at the summary level and de-identified.

IPD Sharing Time Frame

Data sharing requests will continuously be reviewed on a case-to-case basis. Time frames will be according to the most DAAC terms of reference and governance rules.

IPD Sharing Access Criteria

The DAAC will review the requests for access to clinical data and biologic data/samples collected through the UCAN CAN-DU project for the purposes of addressing secondary research questions. Assessments include, but not limited to, scientific merits, research environment, potential impact and significance, feasibility, overlap with other research questions, financial plan, and involvement with patient partners.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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