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CAPRI National Juvenile Idiopathic Arthritis Registry

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ClinicalTrials.gov Identifier: NCT03245801
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
IWK Health Centre
London Health Sciences Centre
Royal University Hospital Foundation
University of Manitoba
University of Calgary
Alberta Children's Hospital
Memorial University of Newfoundland
McMaster University
McMaster Children's Hospital
McGill University Health Center
Université de Montréal
Information provided by (Responsible Party):
Jaime Guzman, University of British Columbia

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 10 years producing groundbreaking research on the modern course and outcomes of JIA. CAPRI proposes an ongoing universal registry of Canadian children with JIA that will collect longitudinal data on disease course, outcomes and adverse events to inform healthcare decisions and to gain new insights into the disease and its treatment.

Condition or disease
Juvenile Idiopathic Arthritis (JIA)

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Canadian Alliance of Pediatric Rheumatology Investigators National Juvenile Idiopathic Arthritis Registry
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of Children with Clinical inactive disease [ Time Frame: At one year ]
    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).


Secondary Outcome Measures :
  1. Juvenile Arthritis Disease Activity Score [ Time Frame: One year ]
    This is an accepted validated measure composed of the sum of physician global assessment, parent global assessment and up to 10 active joints.

  2. Pain intensity [ Time Frame: One year ]
    Severity of arthritis pain in the last week, from 0 to 10

  3. Juvenile Arthritis Quality of Life Questionnaire [ Time Frame: One year ]
    Composite measure of quality of life with total of 72 items, score from 1 (best) to 7 (worst) quality of life.

  4. Childhood Health Assessment Questionnaire Disability Index [ Time Frame: One year ]
    Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric rheumatology clinic patients at study sites
Criteria

Inclusion Criteria:

  1. All patients newly diagnosed with JIA within the last 3 months
  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:

  1. Patients with an unconfirmed JIA diagnosis
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245801


Contacts
Contact: Jaime Guzman, MD, FRCPC 604-875-2437 jguzman@cw.bc.ca
Contact: Ritu Ratan, M.B.B.S, MPH 6048752000 ext 4839 ritu.ratan@cw.bc.ca

Locations
Canada, Alberta
University of Calgary / Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada
Contact: Heinrike Schmeling, MD         
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada
Contact: Dax Rumsey, MD, FRCP(C)         
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Principal Investigator: Jaime Guzman, MD, FRCPC         
Canada, Manitoba
University of Manitoba/Children's hospital research institute Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Kerstin Gerhold, MD, MSc         
Canada, Newfoundland and Labrador, Canada
Memorial University/Janeway Childrens Health and Rehabilitation Centre Not yet recruiting
St. John's, Newfoundland and Labrador, Canada, Canada
Contact: Paul Dancey, MD,FRCPC         
Canada, Nova Scotia
IIWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Adam Huber, MD         
Canada, Ontario
McMaster University/McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada
Contact: Michelle Batthish, MSc,MD,FRCPC         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: Roberta Berard, MD         
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada
Principal Investigator: Ciaran Duffy, MD         
Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada
Contact: Linda Hiraki, MD,FRCPC,MS         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada
Contact: Gaëlle Chédeville, MD         
Université de Montréal Not yet recruiting
Montréal, Quebec, Canada
Contact: Julie Barsalou, MD         
University of Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada
Contact: Alessandra Bruns, MD         
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada
Contact: Alan Rosenberg, BA,MD,FRCPC         
Sponsors and Collaborators
University of British Columbia
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
IWK Health Centre
London Health Sciences Centre
Royal University Hospital Foundation
University of Manitoba
University of Calgary
Alberta Children's Hospital
Memorial University of Newfoundland
McMaster University
McMaster Children's Hospital
McGill University Health Center
Université de Montréal
Investigators
Study Chair: Jaime Guzman, MD, FRCPC University of British Columbia
Principal Investigator: 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 Center
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

Additional Information:
Publications:

Responsible Party: Jaime Guzman, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03245801     History of Changes
Other Study ID Numbers: H16-00309
UBC Number: F15-01938 ( Other Grant/Funding Number: Arthritis Society )
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jaime Guzman, University of British Columbia:
Juvenile idiopathic arthritis
Canada
Registry
Clinical outcomes
Adverse events
CAPRI

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases