Study Results
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Basic Information
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RECRUITING
1238 participants
OBSERVATIONAL
2017-02-01
2026-02-01
Brief Summary
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Detailed Description
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International League of Associations for Rheumatology (ILAR) criteria classify children with JIA into seven categories based on clinical manifestations and laboratory tests. Current practice recommendations propose use of medications tailored according to JIA category or according to treatment groups defined by number of joints affected and features of poor prognosis. In general, initial treatment with intraarticular corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs) is recommended for JIA affecting a few joints; while methotrexate and biologic agents are recommended when many joints are affected and for children with features of poor prognosis.
CAPRI is the collaborative network of all pediatric rheumatology investigators across Canada, with an outstanding track record of successful collaboration in a number of research projects. Since 2005 CAPRI investigators have worked on a project called ReACCH-Out, a team grant funded by the Canadian Institutes of Health Research (CIHR) to study the impact of arthritis on Canadian children. CAPRI developed a robust web-based longitudinal data base and enrolled 1,500 newly diagnosed children with JIA during a five year period. This study has resulted in one of the largest longitudinal JIA cohorts in the world and six published scientific manuscripts to date. Most importantly it has provided essential new answers about disease presentation and short to medium-term prognosis. The initial study was leveraged into two subsequent studies also funded by CIHR: Biologically Based Outcomes Predictors in JIA (BBOP) and Linking Exercise, Activity, and Pathophysiology in Canadian children with Arthritis (LEAP).
Continuation of this effort with a new registry can illuminate longer term prognosis for JIA patients. The rapidly changing landscape of available therapies necessitates maintenance and extension of the registry to elucidate the changing prognosis in different therapeutic eras, and to enable contemporary prognostic counseling to new patients and their families.
In April 2015, The Arthritis Society provided an infrastructure award to continue, expand and strengthen a harmonized Canadian registry of patients with JIA, to support pediatric rheumatology research. This award has been enriched with other sources to include assessment of medication adverse events, thus providing the funding that will be used for this CAPRI national JIA registry.
2. GOALS AND PRINCIPLES
The goal of the CAPRI JIA registry is to prospectively collect information on disease course, outcomes and medication adverse events among Canadian children with JIA. The registry will:
1. Provide answers about the expected disease outcomes and the risks of medication adverse events for patients and care providers.
2. Contribute to new insights about JIA and its treatment through yearly updates of registry findings and publication of scientific papers.
3. Allow Canadian researchers to answer their own research questions about JIA.
4. Allow comparison of JIA outcomes and treatments across Canada and with other jurisdictions, in support of quality improvement initiatives.
The registry will operate following five principles:
Universal: all children newly diagnosed with JIA across Canada will be eligible.
Simple: the registry will require minimum training and time to collect information.
High-Quality: the registry will emphasize quality over quantity of data and the quality of data will be continually monitored.
Clinician-centered: the registry will ensure that physicians who follow children with JIA are engaged and see value from their contribution to the registry.
Linkable: the registry will make provisions for future linkages to existing research and healthcare cohorts, to Statistics Canada data and to other databases.
3\. METHODS
3.1 Registry oversight
The registry will be managed through CAPRI. A registry committee of CAPRI has been established, with the following responsibilities:
1. Oversight of all registry functions.
2. Report to CAPRI executive.
3. Supervision of the registry coordinator.
The registry committee consists of CAPRI members who volunteer for a 2-year renewable term. The group has elected a chair (Dr. Jaime Guzman) who will be the direct contact for the registry coordinator, organize teleconferences and provide reports to the chair of CAPRI. The registry committee chair will sit on the CAPRI executive committee.
Funding from registry sponsors will come to a central registry account. The registry committee and its chair will be responsible for fund payments, as per agreed CAPRI budget. Financial accounting will be managed by the registry coordinator.
The registry will be subject to the following reporting processes:
1. Annual report to registry sponsors including budget use and progress.
2. Bi-annual report to the CAPRI membership on progress, registry statistics, and budget. A copy of the bi-annual report will be sent to registry sponsors.
3. Annual research output report after the first year of registry operations.
4. Annual update on registry findings to be shared with families and care providers.
3.2 Set up of registry centres All CAPRI centres and pediatric rheumatology practices in Canada are eligible to participate in the registry. Participating sites will designate a registry site director for communication and management purposes. Each site will be responsible for patient enrollment, data entry, and maintenance of appropriate registry records for their site. The registry site director will manage their own site budget, and be required to provide annual budget records.
The registry coordinator will assist each registry site in completing the following steps necessary for set up:
1. Submission of registry protocol for ethics review by the local ethics board and amendments as needed
2. Deciding on the logistics of patient recruitment and registration that best fit with the centre current practices and processes.
3. Deciding on the logistics of data collection that best fit their local practices and processes, including timelines for data submission and locking of the data.
4. Review and agree on the processes for data quality monitoring.
3.3 Patient recruitment and registration At the medical visit where a new diagnosis of JIA is made, the pediatric rheumatologist making the diagnosis will introduce the registry to the patient. The registry site director or delegate will then provide the family with full information about the registry and ask for their written consent. ReACCh-Out and LEAP participants will be asked to re-consent for the registry at their first regular visit.
Registration includes three steps:
1. Review and signing of the consent form
2. Assignment of a unique registry identification number by an automated online system
3. Collection of initial registry data as described below
3.4 Data collection The registry will collect data from the pediatric rheumatologist caring for the child, and from the child and the child's parent or guardian. Data will be collected from the physician and families at registration followed by a minimum set of data at every subsequent clinic visit. Additional data once yearly at a visit close to the anniversary of the diagnosis will be collected from families. All data will be collected at clinic visits and there will be no visits booked specifically for registry purposes.
The primary method of data collection from physicians will be direct entry online using a secure web site located at a Canadian academic centre, via computer or smart phone. The secondary method of data collection will be in paper forms for physicians who prefer that method. Data in paper forms will then be entered online by research assistants.
The primary method of data collection from families will be in paper forms. The answers will be verified by research assistants and then entered online. The secondary method of data collection will be direct entry online for centres where existing infrastructure allows for direct entry by families at the time of the visit.
3.5 Protection of privacy and confidentiality All data collected will be handled in accordance with federal and provincial personal information legislation. Information that would allow identification of a child, such as name, date of birth and address will only be collected in the consent form. This information will be separate from registry information and will not be available in any online system. All subsequent data collection will have no personal identifying information, only the registry identification number.
The de-identified registry information will be stored online in a dedicated RedCap server at a Canadian academic centre that complies with all encryption and audit regulatory requirements. As this is an ongoing registry de-identified electronic records will be kept indefinitely in the secure servers. There is a possibility in the future to have international collaborations to help with data analysis. In this case, data sent outside of Canada will not contain any personal identifying information and will be strictly de-identified.
Any de-identified paper records used during the process of entering information in the registry will be kept under locked storage for ten years and then destroyed. They are to be used in case of need for confirmation of the veracity of the data for scientific publication purposes.
3.6 Data quality monitoring
The continuous monitoring of data quality is an essential function of the registry and the major responsibility of the registry coordinator. The registry committee and its chair bear final accountability for the quality of the data entered in the registry. The following four complementary methods will ensure the data contained in the registry is complete and of the highest possible quality:
1. Quality control during data entry: Defines the automatic quality controls set up as part of data entry for each questionnaire or form.
2. Daily quality control by registry coordinator: Defines the daily activities of the registry coordinator to monitor data quality and actions to follow through on issues identified.
3. Quality control at periodic centre audits: Defines indications for quality audits, their periodicity and how their results are assessed and followed through.
4. Monthly update on quality control to registry chair: defines the components of the monthly quality update, how it is prepared and how it is assessed by the chair.
3.7 Access to data To assist healthcare provision: Patients and their physicians will have access to their data to obtain estimates of expected outcomes and risks of side effects based on analyses of registry data.
To answer research questions: CAPRI and non-CAPRI researchers may request access to registry data to answer research questions.
To assist planning and program development: Healthcare organizations, registry sponsors, health authorities and ministries of health services, may request access to summary statistics or de-identified group data for use in knowledge translation activities or to assist in their planning of programs and delivery of care.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. All patients who participated in the original ReACCh-Out study
3. LEAP study patients from 'newly diagnosed' and 'ReACCh-Out' cohorts who have completed their two year follow up in LEAP
Exclusion Criteria
2. Patients diagnosed with JIA more than 3 months prior to the clinic visit, who were not followed in LEAP and /or ReACCh-Out studies.
3. If the family as a whole is unable to answer questionnaires in English or French
18 Years
ALL
No
Sponsors
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Children's Hospital of Eastern Ontario
OTHER
The Hospital for Sick Children
OTHER
IWK Health Centre
OTHER
London Health Sciences Centre
OTHER
Royal University Hospital Foundation
OTHER
University of Manitoba
OTHER
University of Calgary
OTHER
Alberta Children's Hospital
OTHER
Memorial University of Newfoundland
OTHER
McMaster University
OTHER
McMaster Children's Hospital
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Université de Montréal
OTHER
Laval University
OTHER
University of British Columbia
OTHER
Responsible Party
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Jaime Guzman
Clinical Associate Professor
Principal Investigators
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Jaime Guzman, MD, FRCPC
Role: STUDY_CHAIR
University of British Columbia
Adam Huber, MD
Role: PRINCIPAL_INVESTIGATOR
IIWK Health Centre, Halifax, Nova Scotia, Canada
Ciaran Duffy, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario, Ottawa, Ontario
Gaëlle Chédeville, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Heinrike Schmeling, MD
Role: PRINCIPAL_INVESTIGATOR
Alberta Children's Hospital
Linda Hiraki, MD,FRCPC,MS
Role: PRINCIPAL_INVESTIGATOR
Hospital for Sick Children (SickKids)
Heinrike Schmeling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary / Alberta Children's Hospital
Susanne Benseler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary / Alberta Children's Hospital
Marinka Twilt, MD MSCE PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary / Alberta Children's Hospital
Locations
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University of Calgary / Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
University of Manitoba/Children's hospital research institute
Winnipeg, Manitoba, Canada
Memorial University/Janeway Childrens Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, Canada
IIWK Health Centre
Halifax, Nova Scotia, Canada
McMaster University/McMaster Children's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Université de Montréal
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
CHU Québec - Universite Laval
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Heinrike Schmeling, MD
Role: primary
Dax Rumsey, MD, FRCP(C)
Role: primary
Lily Lim, MD, PhD
Role: primary
Paul Dancey, MD,FRCPC
Role: primary
Adam M Huber, MD
Role: primary
Michelle Batthish, MSc,MD,FRCPC
Role: primary
Roberta Berard, MD
Role: primary
Brian Feldman, MD,FRCPC,MSc
Role: primary
Gaëlle Chédeville, MD
Role: primary
Jean Jacques De Bruycker, MD
Role: primary
Alessandra Bruns, MD
Role: primary
Mehul Jariwala, MD
Role: primary
Jean Philippe Proulx-Gauthier, MD
Role: primary
References
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Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2. No abstract available.
Shiff NJ, Lix LM, Oen K, Joseph L, Duffy C, Stringer E, Tucker LB, Svenson LW, Belisle P, Bernatsky S. Chronic inflammatory arthritis prevalence estimates for children and adolescents in three Canadian provinces. Rheumatol Int. 2015 Feb;35(2):345-50. doi: 10.1007/s00296-014-3085-0. Epub 2014 Jul 15.
Oen K. Long-term outcomes and predictors of outcomes for patients with juvenile idiopathic arthritis. Best Pract Res Clin Rheumatol. 2002 Jul;16(3):347-60.
Ravelli A, Martini A. Early predictors of outcome in juvenile idiopathic arthritis. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S89-93.
Adib N, Silman A, Thomson W. Outcome following onset of juvenile idiopathic inflammatory arthritis: I. frequency of different outcomes. Rheumatology (Oxford). 2005 Aug;44(8):995-1001. doi: 10.1093/rheumatology/keh620. Epub 2005 Apr 12.
Dueckers G, Guellac N, Arbogast M, Dannecker G, Foeldvari I, Frosch M, Ganser G, Heiligenhaus A, Horneff G, Illhardt A, Kopp I, Krauspe R, Markus B, Michels H, Schneider M, Singendonk W, Sitter H, Spamer M, Wagner N, Niehues T. Evidence and consensus based GKJR guidelines for the treatment of juvenile idiopathic arthritis. Clin Immunol. 2012 Feb;142(2):176-93. doi: 10.1016/j.clim.2011.10.003. Epub 2011 Oct 26.
Beukelman T, Patkar NM, Saag KG, Tolleson-Rinehart S, Cron RQ, DeWitt EM, Ilowite NT, Kimura Y, Laxer RM, Lovell DJ, Martini A, Rabinovich CE, Ruperto N. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res (Hoboken). 2011 Apr;63(4):465-82. doi: 10.1002/acr.20460.
Oen K, Duffy CM, Tse SM, Ramsey S, Ellsworth J, Chedeville G, Chetaille AL, Saint-Cyr C, Cabral DA, Spiegel LR, Schneider R, Lang B, Huber AM, Dancey P, Silverman E, Rosenberg AM, Cameron B, Johnson N, Dorval J, Scuccimarri R, Campillo S, Petty RE, Duffy KN, Boire G, Haddad E, Houghton K, Laxer R, Turvey SE, Miettunen P, Gross K, Guzman J, Benseler S, Feldman BM, Espinosa V, Yeung RS, Tucker L. Early outcomes and improvement of patients with juvenile idiopathic arthritis enrolled in a Canadian multicenter inception cohort. Arthritis Care Res (Hoboken). 2010 Apr;62(4):527-36. doi: 10.1002/acr.20044.
Guzman J, Oen K, Huber AM, Watanabe Duffy K, Boire G, Shiff N, Berard RA, Levy DM, Stringer E, Scuccimarri R, Morishita K, Johnson N, Cabral DA, Rosenberg AM, Larche M, Dancey P, Petty RE, Laxer RM, Silverman E, Miettunen P, Chetaille AL, Haddad E, Houghton K, Spiegel L, Turvey SE, Schmeling H, Lang B, Ellsworth J, Ramsey SE, Bruns A, Roth J, Campillo S, Benseler S, Chedeville G, Schneider R, Tse SM, Bolaria R, Gross K, Feldman B, Feldman D, Cameron B, Jurencak R, Dorval J, LeBlanc C, St Cyr C, Gibbon M, Yeung RS, Duffy CM, Tucker LB; ReACCh-Out investigators. The risk and nature of flares in juvenile idiopathic arthritis: results from the ReACCh-Out cohort. Ann Rheum Dis. 2016 Jun;75(6):1092-8. doi: 10.1136/annrheumdis-2014-207164. Epub 2015 May 18.
Guzman J, Oen K, Tucker LB, Huber AM, Shiff N, Boire G, Scuccimarri R, Berard R, Tse SM, Morishita K, Stringer E, Johnson N, Levy DM, Duffy KW, Cabral DA, Rosenberg AM, Larche M, Dancey P, Petty RE, Laxer RM, Silverman E, Miettunen P, Chetaille AL, Haddad E, Houghton K, Spiegel L, Turvey SE, Schmeling H, Lang B, Ellsworth J, Ramsey S, Bruns A, Campillo S, Benseler S, Chedeville G, Schneider R, Yeung R, Duffy CM; ReACCh-Out investigators. The outcomes of juvenile idiopathic arthritis in children managed with contemporary treatments: results from the ReACCh-Out cohort. Ann Rheum Dis. 2015 Oct;74(10):1854-60. doi: 10.1136/annrheumdis-2014-205372. Epub 2014 May 19.
Shiff NJ, Tucker LB, Guzman J, Oen K, Yeung RS, Duffy CM. Factors associated with a longer time to access pediatric rheumatologists in Canadian children with juvenile idiopathic arthritis. J Rheumatol. 2010 Nov;37(11):2415-21. doi: 10.3899/jrheum.100083. Epub 2010 Aug 17.
Oen K, Tucker L, Huber AM, Miettunen P, Scuccimarri R, Campillo S, Cabral DA, Feldman BM, Tse S, Chedeville G, Spiegel L, Schneider R, Lang B, Ellsworth J, Ramsey S, Dancey P, Silverman E, Chetaille AL, Cameron B, Johnson N, Dorval J, Petty RE, Duffy KW, Boire G, Haddad E, Houghton K, Saint-Cyr C, Turvey SE, Benseler S, Cheang M, Yeung RS, Duffy CM. Predictors of early inactive disease in a juvenile idiopathic arthritis cohort: results of a Canadian multicenter, prospective inception cohort study. Arthritis Rheum. 2009 Aug 15;61(8):1077-86. doi: 10.1002/art.24539.
Related Links
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Juvenile idiopathic arthritis
Other Identifiers
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UBC Number: F15-01938
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H16-00309
Identifier Type: -
Identifier Source: org_study_id
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