NCT03904459

Brief Summary

The Norwegian JIA Study (NorJIA) is a prospective, longitudinal, multicenter, observational study of 250 children with juvenile idiopathic arthritis (JIA) and 250 healthy controls, attending the three Norwegian university clinics in Bergen, Tromsø, or Trondheim. The study will run over 5 years, and include extensive clinical, laboratory, radiological and oral examinations at baseline and after 2 years follow-up. There will be a special focus on the jaw (temporomandibular joints) with extensive imaging and clinical examination, aiming at establishing scoring systems for active and chronic disease and growth disturbances. Another focus is to study mouth and teeth problems, such as caries and gingivitis, and look for predictors of poor oral health in children with JIA compared to health peers. As chronic inflammation, reduced physical activity and certain anti-inflammatory drugs can be detrimental for bone strength and development, the investigators also want to study the bone health of children with JIA, and look for predictors of poor bone mineral density. The results of the study may contribute to better diagnostics of inflammatory processes, earlier detection of poor oral or bone health, and thereby point to possible prevention strategies to increase quality of life for children with JIA in the future.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

March 25, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

3.4 years

First QC Date

April 3, 2019

Last Update Submit

April 3, 2019

Conditions

Arthritis, Juvenile

Keywords

Temporomandibular JointOral HealthBone & BonesBone DensityQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Bone mineral density

    measured by a Dual-energy X-ray absorptiometry (DXA) scan of the hip, lumbar spine and total body with body composition and expressed in Z scores, number of standard deviations (SD) from the expected mean according to sex and age

    2 years

  • Joint inflammation and damage

    defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints

    2 years

  • caries experience DMFTS/dmfts

    Measured by: DMFTS = Number of decayed/missed/filled permanent teeth in the age group 12-17 years, or dmfts = No. of decayed/missed/filled primary teeth in children up to 11 years

    2 years

Study Arms (2)

cases

Children with juvenile idiopathic arthritis

Other: no intervention

controls

healthy children

Other: no intervention

Interventions

no interventionOTHER
casescontrols

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with juvenile idiopathic arthritis followed at any of the three participating centers according to hospital files. Controls are recruited at The Oral Health Centre of Expertise (Tk) Mid-Norway (TkMN), TkWest or at Tk Northern Norway (TkNN) from their lists of children due for a free visit to the dentist according to the Norwegian public dental service policy.

You may qualify if:

  • fulfilling the ILAR criteria for juvenile idiopathic arthritis

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Oral Health Centre of Expertise West Norway

Bergen, Norway

Location

Oral Health Centre of Expertise North Norway

Tromsø, Norway

Location

University Hospital in North Norway

Tromsø, Norway

Location

Oral heath Centre of Expertise Mid Norway

Trondheim, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (5)

  • Lundestad A, Cetrelli L, Angenete OW, Augdal TA, Tylleskar K, Nordal EB, Rosendahl K, Hoftun GB, Hoff M, Romundstad PR, Rygg M. Bone health in juvenile idiopathic arthritis compared with controls based on a Norwegian observational study. RMD Open. 2025 Jun 19;11(2):e005605. doi: 10.1136/rmdopen-2025-005605.

    PMID: 40537274DERIVED

  • Arneng SM, Jenssen IP, Lundestad A, Cetrelli L, Angenete O, Nordal E, Tylleskar KB, Romundstad PR, Rygg M. The patient's voice: a cross-sectional study of physical health and disability in juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2024 Nov 18;22(1):100. doi: 10.1186/s12969-024-01034-7.

    PMID: 39558411DERIVED

  • Halbig JM, Jonsson B, Gil EG, Astrom AN, Rypdal V, Frid P, Augdal TA, Fischer J, Cetrelli L, Rygg M, Lundestad A, Tylleskar K, Nordal E; Norwegian JIA Study - Temporo-mandibular Involvement, Oral Health, Uveitis, Bone Health, Quality of Life in Children with Juvenile Idiopathic Arthritis. Oral health-related quality of life, impaired physical health and orofacial pain in children and adolescents with juvenile idiopathic arthritis - a prospective multicenter cohort study. BMC Oral Health. 2023 Nov 20;23(1):895. doi: 10.1186/s12903-023-03510-0.

    PMID: 37986155DERIVED

  • Augdal TA, Angenete OW, Shi XQ, Sall M, Fischer JM, Nordal E, Rosendahl K. Cone beam computed tomography in the assessment of TMJ deformity in children with JIA: repeatability of a novel scoring system. BMC Oral Health. 2023 Jan 10;23(1):12. doi: 10.1186/s12903-022-02701-5.

    PMID: 36627622DERIVED

  • Fischer J, Skeie MS, Rosendahl K, Tylleskar K, Lie S, Shi XQ, Gil EG, Cetrelli L, Halbig J, von Wangenheim Marti L, Rygg M, Frid P, Stoustrup P, Rosen A. Prevalence of temporomandibular disorder in children and adolescents with juvenile idiopathic arthritis - a Norwegian cross- sectional multicentre study. BMC Oral Health. 2020 Oct 13;20(1):282. doi: 10.1186/s12903-020-01234-z.

    PMID: 33050890DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, stimulated and unstimulated saliva

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ansgar Berg

    Department of Pediatrics, Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

March 25, 2015

Primary Completion

August 17, 2018

Study Completion

June 20, 2020

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(5)