UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
UCAN CAN-DU
1 other identifier
observational
4,100
2 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2018
CompletedFirst Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
ExpectedAugust 19, 2024
August 1, 2024
6.6 years
April 30, 2024
August 16, 2024
Conditions
Outcome Measures
Primary Outcomes (12)
Prospectively collect essential clinical data elements from children with new onset JIA
Up to 24 months
Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA
Up to 24 months
Evaluate clinical outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Up to 24 months
Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA.
Up to 12 months
Prospectively collect essential biological data elements from children with new onset JIA
Up to 24 months
Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA
Up to 24 months
Evaluate biological outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Up to 24 months
Prospectively collect essential biological data elements from children with extreme phenotypes of JIA
Up to 12 months
Prospectively collect essential socioeconomic data elements from children with new onset JIA
Up to 12 months
Evaluate the socioeconomic impact associated with the use of therapeutic agents in children with JIA
Up to 12 months
Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA
Up to 24 months
Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA
Up to 12 months
Study Arms (4)
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
Eligibility Criteria
Participants will be recruited from the patient population of a UCAN study site.
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital for Sick Childrenlead
- Canadian Institutes of Health Research (CIHR)collaborator
- Genome Canadacollaborator
- Genome Albertacollaborator
- The Arthritis Society, Canadacollaborator
- ReumaNederlandcollaborator
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Alberta Children's Hospitalcollaborator
- Ontario Genomicscollaborator
Study Sites (19)
Alberta Children's Hospital - University of Calgary
Calgary, Alberta, T3B 6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Children's Hospital Health Science Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Janeway Children's Hospital and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5, Canada
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8, Canada
Montréal Children's Hospital
Montreal, Quebec, H4A 3J1, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A2, Canada
Amalia Children's Hospital, Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Sint Maartenskinderkliniek
Boxmeer, North Brabant, 6574 NA, Netherlands
Emma Children's Hospital, Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
Willem-Alexander Children's Hospital, LUMC
Leiden, South Holland, 2333 ZA, Netherlands
Sophia Children's Hospital, EMC
Rotterdam, South Holland, 3015 CN, Netherlands
Beatrix Children's Hospital, UMCG
Groningen, 9713 GZ, Netherlands
Wilhelmina Children's Hospital, UMCU
Utrecht, 3584 EA, Netherlands
Biospecimen
DNA, RNA, plasma, serum, cell
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Staff Physician and Senior Scientist
Study Record Dates
First Submitted
April 30, 2024
First Posted
August 19, 2024
Study Start
August 24, 2018
Primary Completion
March 30, 2025
Study Completion (Estimated)
March 30, 2027
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- 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.
- 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.
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.