Juvenile Idiopathic ArthritisNCT02223195
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by Folktandvården Stockholms län AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 1. 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be collected and analyzed with respect to biomarkers.
One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Inclusion criteria are:
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology
Exclusion criteria are:
- 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. 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.
The control group of 100 age and sex matched healthy children will be included at Folktandvården Stockholms Län AB.
Inclusion criteria are:
- age between 7 and 14 years
Exclusion criteria are:
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- A diagnosis of JIA
- other conditions or diseases than JIA that may cause orofacial pain. 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile Idiopathic Arthritis, Saliva
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.
Saliva sampels will be colleceted and analysed
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startMar 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folktandvården Stockholms län AB
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Malin Collin, Folktandvården Stockholms län AB
- Investigators
- Britt Hedenberg Magnusson, PhD DDS, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223195
- Sponsor's protocol ID
- MC 2
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2014
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT02223195
- Acronym / sponsor ID
- MC 2
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile Idiopathic Arthritis, Saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Folktandvården Stockholms län ABOther government
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be collected and analyzed with respect to biomarkers.
One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Inclusion criteria are:
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology
Exclusion criteria are:
- 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. 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.
The control group of 100 age and sex matched healthy children will be included at Folktandvården Stockholms Län AB.
Inclusion criteria are:
- age between 7 and 14 years
Exclusion criteria are:
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- A diagnosis of JIA
- other conditions or diseases than JIA that may cause orofacial pain. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 1. 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.
Time frame: one day
Saliva sampels will be colleceted and analysed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Hedenberg Magnusson, PhD DDS principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Folktandvården Stockholms län AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.