NCT03245801

Brief Summary

Juvenile Idiopathic Arthritis (JIA) is a disorder of unknown cause characterized by chronic inflammation of the joints and other organs. It affects about 1 in a 1000 Canadian children and if untreated it can produce lifelong disability. The Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) includes most pediatric rheumatologists in Canada. They have successfully collaborated for the past 20 years producing groundbreaking research on the modern course and outcomes of JIA. The CAPRI JIA Registry is an ongoing universal registry of Canadian children with JIA that collects longitudinal data on disease course, outcomes and adverse events to inform healthcare decisions and to gain new insights into the disease and its treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

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

February 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

9 years

First QC Date

July 17, 2017

Last Update Submit

June 24, 2025

Conditions

Juvenile Idiopathic Arthritis (JIA)

Keywords

Juvenile idiopathic arthritisCanadaRegistryClinical outcomesAdverse eventsCAPRI

Outcome Measures

Primary Outcomes (1)

  • Proportion of Children with Clinical inactive disease

    This is an accepted validated composite measure requiring all of the following: No active joints, no extra-articular manifestations, a physician global assessment of disease activity of less than 1, morning stiffness of 15 min or less, and normal inflammatory markers (ESR or CRP).

    At one year

Secondary Outcomes (4)

  • Juvenile Arthritis Disease Activity Score

    One year

  • Pain intensity

    One year

  • Juvenile Arthritis Quality of Life Questionnaire

    One year

  • Childhood Health Assessment Questionnaire Disability Index

    One year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric rheumatology clinic patients at study sites

You may qualify if:

  • All patients newly diagnosed with JIA within the last 3 months
  • All patients who participated in the original ReACCh-Out study
  • LEAP study patients from 'newly diagnosed' and 'ReACCh-Out' cohorts who have completed their two year follow up in LEAP

You may not qualify if:

  • Patients with an unconfirmed JIA diagnosis
  • Patients diagnosed with JIA more than 3 months prior to the clinic visit, who were not followed in LEAP and /or ReACCh-Out studies.
  • If the family as a whole is unable to answer questionnaires in English or French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Calgary / Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

University of Manitoba/Children's hospital research institute

Winnipeg, Manitoba, Canada

RECRUITING

Memorial University/Janeway Childrens Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada, Canada

RECRUITING

IIWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

McMaster University/McMaster Children's Hospital

Hamilton, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Université de Montréal

Montreal, Quebec, Canada

RECRUITING

University of Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

CHU Québec - Universite Laval

Québec, Canada

RECRUITING

Related Publications (12)

  • 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.

    PMID: 14760812BACKGROUND

  • 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.

    PMID: 25023756BACKGROUND

  • 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.

    PMID: 12387804BACKGROUND

  • Ravelli A, Martini A. Early predictors of outcome in juvenile idiopathic arthritis. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S89-93.

    PMID: 14969057BACKGROUND

  • 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.

    PMID: 15827045BACKGROUND

  • 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.

    PMID: 22154868BACKGROUND

  • 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.

    PMID: 21452260BACKGROUND

  • 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.

    PMID: 20391508BACKGROUND

  • 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.

    PMID: 25985972BACKGROUND

  • 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.

    PMID: 24842571BACKGROUND

  • 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.

    PMID: 20716664BACKGROUND

  • 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.

    PMID: 19644903BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jaime Guzman, MD, FRCPC

    University of British Columbia

    STUDY CHAIR

  • Adam Huber, MD

    IIWK Health Centre, Halifax, Nova Scotia, Canada

    PRINCIPAL INVESTIGATOR

  • Ciaran Duffy, MD

    Children's Hospital of Eastern Ontario, Ottawa, Ontario

    PRINCIPAL INVESTIGATOR

  • Gaëlle Chédeville, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • Heinrike Schmeling, MD

    Alberta Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Linda Hiraki, MD,FRCPC,MS

    Hospital for Sick Children (SickKids)

    PRINCIPAL INVESTIGATOR

  • Heinrike Schmeling, MD

    University of Calgary / Alberta Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Susanne Benseler, MD, PhD

    University of Calgary / Alberta Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Marinka Twilt, MD MSCE PhD

    University of Calgary / Alberta Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Guzman, MD, FRCPC

CONTACT

604-875-2437jguzman@cw.bc.ca

Martha Sieres

CONTACT

6048752000martha.sieres@cw.bc.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

July 17, 2017

First Posted

August 10, 2017

Study Start

February 1, 2017

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

CAPRI researchers who seek to use de-identified registry data to answer research questions not contemplated in this protocol will apply through the CAPRI Scientific Protocol Evaluation Committee (SPEC) process and produce proof of ethics board approval before release of data. Registry site directors will have access to their local data for smaller local research projects. Provision of information regarding project title, aim, and any ensuing publication will be required so that a complete record of research projects can be maintained. Non-CAPRI researchers who seek access to registry data must have a research team that includes at least one CAPRI member and apply for use through the CAPRI SPEC. Proof of ethics board approval will be required before release of data. All research abstracts, presentations and publications using registry data must acknowledge registry sponsors.The registry committee and CAPRI executive will determine data access recovery fees.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Ongoing, as long as the Registry is in operation.
Access Criteria
Non-CAPRI researchers who seek access to registry data must have a research team that includes at least one CAPRI member and apply for use through the CAPRI SPEC. Proof of ethics board approval will be required before release of data.

Locations

CA(15)