EpidemiologyNCT01905319
Juvenile Idiopathic Arthritis in Children in Estonia.
An observational study of Epidemiology, run by University of Tartu.
Trial summary
Aims of the study: to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical subtypes in Estonia for the years 1998-2000; to examine the course and short-term clinical outcome of JIA. Method: a prospective population-based study carried on in 14 counties of Estonia Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Epidemiology
- What is being tested?
- Blood collecting for storage of samples
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Dec 2002
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: During years 1998-2000, 162 newly-diagnosed juvenile idiopathic arthritis cases from 14 counties of Estonia, were included to the study, among them 76 boys and 86 girls.
Who may be able to join
- The International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis
- children aged 0-15 years who had arthritis of an unknown cause for at least six weeks with an onset of the disease during the study period
Who cannot join
- Children with infectious arthritis, postinfectious arthritis, traumatic arthritis and systemic connective tissue diseases
About this study
Official title: Juvenile Idiopathic Arthritis in Children in Estonia - an Epidemiological and Clinical Investigation.
Aims of the study:
- to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical subtypes in Estonia for the years 1998-2000;
- to examine the course and short-term clinical outcome of JIA.
Method: a prospective population-based study carried on in 14 counties of Estonia
- Conditions
- Epidemiology
- Being tested
- Blood collecting for storage of samples
- Keywords
- juvenile idiopathic arthritis, incidence rate
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collecting for storage of samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Subsequent new juvenile arthritis cases | During years 1998-2000, all new subsequent cases of juvenile idiopathic arthritis diagnosed in Estonia were included in the study group. Receives: Other: Blood collecting for storage of samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean annual incidence rate of juvenile idiopathic arthritis in Estonia during years 1998-2000.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 1998
- Primary completionDec 2000
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpidemiologyStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Pruunsild, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905319
- Sponsor's protocol ID
- TARLA 0475;DARLA 0500
- Status last verified
- Mar 2020
- First submitted
- 16 Jul 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pullerits R, Schierbeck H, Uibo K, Liivamagi H, Tarraste S, Talvik T, Sundberg E, Pruunsild C. High mobility group box protein 1-A prognostic marker for structural joint damage in 10-year follow-up of patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2017 Feb;46(4):444-450. doi: 10.1016/j.semarthrit.2016.08.017. Epub 2016 Aug 26.
PubMed 27756498
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juvenile Idiopathic Arthritis in Children in Estonia - an Epidemiological and Clinical Investigation.
- ClinicalTrials.gov ID
- NCT01905319
- Acronym / sponsor ID
- TARLA 0475;DARLA 0500
- Conditions
- Epidemiology
- Keywords
- juvenile idiopathic arthritis, incidence rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 23 Jul 2013 (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.
Aims of the study:
- to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical subtypes in Estonia for the years 1998-2000;
- to examine the course and short-term clinical outcome of JIA.
Method: a prospective population-based study carried on in 14 counties of Estonia
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subsequent new juvenile arthritis cases | – | Other: Blood collecting for storage of samplesDuring years 1998-2000, all new subsequent cases of juvenile idiopathic arthritis diagnosed in Estonia were included in the study group. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- During years 1998-2000, 162 newly-diagnosed juvenile idiopathic arthritis cases from 14 counties of Estonia, were included to the study, among them 76 boys and 86 girls.
Key inclusion criteria (2 listed)
- The International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis
- children aged 0-15 years who had arthritis of an unknown cause for at least six weeks with an onset of the disease during the study period
Key exclusion criteria (1 listed)
- Children with infectious arthritis, postinfectious arthritis, traumatic arthritis and systemic connective tissue diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collecting for storage of samples | Other | Subsequent new juvenile arthritis cases |
Primary outcome
Mean annual incidence rate of juvenile idiopathic arthritis in Estonia during years 1998-2000.
Time frame: 3 years
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 25 Mar 2020.
- Derived from this study: PubMed 27756498Pullerits R, Schierbeck H, Uibo K, Liivamagi H, Tarraste S, Talvik T, Sundberg E, Pruunsild C. High mobility group box protein 1-A prognostic marker for structural joint damage in 10-year follow-up of patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2017 Feb;46(4):444-450. doi: 10.1016/j.semarthrit.2016.08.017. Epub 2016 Aug 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology, run by University of Tartu.
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 2 inclusion and 1 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean annual incidence rate of juvenile idiopathic arthritis in Estonia during years 1998-2000. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905319, which also lists 1 linked publication.
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 25 Mar 2020.