UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
NCT ID: NCT06560606
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4100 participants
OBSERVATIONAL
2018-08-24
2027-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≤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
* 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
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Genome Canada
OTHER
Genome Alberta
OTHER
The Arthritis Society, Canada
OTHER
ReumaNederland
UNKNOWN
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Alberta Children's Hospital
OTHER
Ontario Genomics
UNKNOWN
The Hospital for Sick Children
OTHER
Responsible Party
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Rae Yeung
Professor, Staff Physician and Senior Scientist
Principal Investigators
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Rae SM Yeung, MD, PhD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children (SickKids), University of Toronto
Nico Wulffraat, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wilhelmina Children's Hospital, University Medical Center Utrecht
Susa Benseler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Alberta Children's Hospital and Cumming School of Medicine, University of Calgary
Joost Swart, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wilhelmina Children's Hospital, University Medical Center Utrecht
Bas Vastert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wilhelmina Children's Hospital, University Medical Center Utrecht
Locations
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Alberta Children's Hospital - University of Calgary
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Children's Hospital Health Science Centre Winnipeg
Winnipeg, Manitoba, Canada
Janeway Children's Hospital and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Montréal Children's Hospital
Montreal, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Amalia Children's Hospital, Radboudumc
Nijmegen, Gelderland, Netherlands
Sint Maartenskinderkliniek
Boxmeer, North Brabant, Netherlands
Emma Children's Hospital, Amsterdam UMC
Amsterdam, North Holland, Netherlands
Willem-Alexander Children's Hospital, LUMC
Leiden, South Holland, Netherlands
Sophia Children's Hospital, EMC
Rotterdam, South Holland, Netherlands
Beatrix Children's Hospital, UMCG
Groningen, , Netherlands
Wilhelmina Children's Hospital, UMCU
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1771
Identifier Type: -
Identifier Source: org_study_id
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