NCT02223195

Brief Summary

Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA). The hypothesis is that children with JIA will show a different pattern of inflammatory biomarkers in saliva than healthy Children. The null hypothesis is that there are no differences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

4.6 years

First QC Date

August 21, 2014

Last Update Submit

August 4, 2020

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile Idiopathic ArthritisSaliva

Outcome Measures

Primary Outcomes (1)

  • Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.

    Saliva sampels will be colleceted and analysed

    one day

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Group 1: 40 consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included. Group 2: 40 healthy children, age-and sex-matched.

You may qualify if:

  • \. A diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1

You may not qualify if:

  • current malignancies
  • TMJ surgery or trauma within two years
  • Recent intra-articular glucocorticoid injection in TMJ (within 1 month)
  • Other conditions or diseases than JIA that may cause orofacial pain. Fore the controllgroup JIA are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Stockholmslän AB

Stockholm, 17267, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sampels

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Britt Hedenberg Magnusson, PhD DDS

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, DDS

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

March 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

SE(1)