Juvenile Idiopathic ArthritisUCAN CAN-DUNCT06560606
UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
An observational study of Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 4,100 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 24 Aug 2018to 30 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from the patient population of a UCAN study site.
Who may be able to join
- 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)
Show all 19Show fewer
- ≤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)
Who cannot join
- 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
Show all 10Show fewer
- Cohort 3:
- Tapering scheme > 12 months to complete biologics stop
- Cohort 4:
- Arthritis explained by another diagnosis
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
Canada12 sites, 12 recruiting
- Recruiting
Alberta Children's Hospital - University of Calgary
Calgary, Alberta, T3B 6A8
Paivi Miettunen, MD
Nicole Johnson, MD
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Dax G Rumsey, MD, MSc, FRCP(C)
Daniah Basodan, MBBS, FRCP(C)
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Adam Huber, MD
Bianca Lang, MD
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Michelle Batthish, MD
Tania Cellucci
- Recruiting
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Roberta Berard, MD
Jonathan Park, MD
- Recruiting
Montréal Children's Hospital
Montreal, Quebec, H4A 3J1
Claire LeBlanc, M.A, MD, FRCPC, Dip Sport Med
Gaelle Chedeville, MsC, MD
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Michele Gibbon, mgibbon@cheo.on.ca
Ciaran Duffy, MB
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A2
Alan Rosenberg
Mehul Jariwala
- Recruiting
Janeway Children's Hospital and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Paul Dancey, MD, FRCPC
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
Shirley Tse, MD
Deborah Levy, MD
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Lori Tucker, MD, FRCPC
Andrea Human, MD, MScHQ, FRCPC
- Recruiting
Children's Hospital Health Science Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Lily Lim, MBBS, MRCPCH, FRCPC, PhD
Netherlands7 sites, 7 recruiting
- Recruiting
Emma Children's Hospital, Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Dieneke Schonenberg, MD, PhD
Mariken Gruppen, MD
- Recruiting
Sint Maartenskinderkliniek
Boxmeer, North Brabant, 6574 NA
Ellen Schatorjé, MD, PhD
Esther Hoppenreijs, MD
- Recruiting
Beatrix Children's Hospital, UMCG
Groningen, 9713 GZ
Elisabeth Legger, MD
Wineke Armbrust, MD, PhD
- Recruiting
Willem-Alexander Children's Hospital, LUMC
Leiden, South Holland, 2333 ZA
Danielle Brinkman, MD
Petra Hissink Muller, MD
- Recruiting
Amalia Children's Hospital, Radboudumc
Nijmegen, Gelderland, 6525 GA
Ellen Schatorjé, MD, PhD
Esther Hoppenreijs, MD
- Recruiting
Sophia Children's Hospital, EMC
Rotterdam, South Holland, 3015 CN
Philomine van Pelt, MD, PhD
Marleen Verkaaik, MD
- Recruiting
Wilhelmina Children's Hospital, UMCU
Utrecht, 3584 EA
Regina de Geus, r.degeus@umcutrecht.nl
Annet van Royen-Kerkhof, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prospectively collect essential clinical data elements from children with new onset JIA
Measured: Up to 24 months
Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA
Measured: Up to 24 months
Evaluate clinical outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Measured: Up to 24 months
Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA.
Measured: Up to 12 months
Prospectively collect essential biological data elements from children with new onset JIA
Measured: Up to 24 months
Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA
Measured: Up to 24 months
Evaluate biological outcomes associated with the de-prescribing of therapeutic agents in children with JIA
Measured: Up to 24 months
Prospectively collect essential biological data elements from children with extreme phenotypes of JIA
Measured: Up to 12 months
Prospectively collect essential socioeconomic data elements from children with new onset JIA
Measured: Up to 12 months
Evaluate the socioeconomic impact associated with the use of therapeutic agents in children with JIA
Measured: Up to 12 months
Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA
Measured: Up to 24 months
Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start24 Aug 2018
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Genome Canada, Genome Alberta, The Arthritis Society, Canada, ReumaNederland, ZonMw: The Netherlands Organisation for Health Research and Development, Alberta Children's Hospital, Ontario Genomics
- Responsible party
- Principal investigator, Rae Yeung, The Hospital for Sick Children
- Investigators
- Rae SM Yeung, MD, PhD, FRCPC, Principal investigator, The Hospital for Sick Children (SickKids), University of TorontoNico Wulffraat, MD, PhD, Principal investigator, Wilhelmina Children's Hospital, University Medical Center UtrechtSusa Benseler, MD, PhD, Principal investigator, Alberta Children's Hospital and Cumming School of Medicine, University of CalgaryJoost Swart, MD, PhD, Principal investigator, Wilhelmina Children's Hospital, University Medical Center UtrechtBas Vastert, MD, PhD, Principal investigator, Wilhelmina Children's Hospital, University Medical Center Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560606
- Sponsor's protocol ID
- 1771
- Acronym
- UCAN CAN-DU
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
- ClinicalTrials.gov ID
- NCT06560606
- Acronym / sponsor ID
- UCAN CAN-DU / 1771
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Genome Canada, Genome Alberta, The Arthritis Society, Canada, ReumaNederland, ZonMw: The Netherlands Organisation for Health Research and Development, Alberta Children's Hospital, Ontario Genomics
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from the patient population of a UCAN study site.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (10 listed)
- Arthritis explained by another diagnosis
- Joint injections as previous treatment less than 4 weeks prior to enrollment
- Arthritis explained by any other cause
- Start on biologics as an indication for uveitis only
- Tapering scheme > 12 months to complete biologics stop
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospectively collect essential clinical data elements from children with new onset JIA
Time frame: Up to 24 months
Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA
Time frame: 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
Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA.
Time frame: Up to 12 months
Prospectively collect essential biological data elements from children with new onset JIA
Time frame: Up to 24 months
Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA
Time frame: 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
Prospectively collect essential biological data elements from children with extreme phenotypes of JIA
Time frame: Up to 12 months
Prospectively collect essential socioeconomic data elements from children with new onset JIA
Time frame: 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
Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA
Time frame: Up to 24 months
Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rae SM Yeung, MD, PhD, FRCPC principal investigator
The Hospital for Sick Children (SickKids), University of Toronto
Nico Wulffraat, MD, PhD principal investigator
Wilhelmina Children's Hospital, University Medical Center Utrecht
Susa Benseler, MD, PhD principal investigator
Alberta Children's Hospital and Cumming School of Medicine, University of Calgary
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Mosoiu (416-813-7654 ext. 302495, alexander.mosiu@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospectively collect essential clinical data elements from children with new onset JIA (time frame: Up to 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.