Juvenile Idiopathic ArthritisNCT00801593
Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Steroid injection into the TMJs.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jun 2010
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with JIA.
Who may be able to join
- Children with defined JIA.
Who cannot join
- Children without defined diagnosis of JIA.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Children's Hospital
Tübingen, Baden-Wurttemberg, 72076
Nikolay Tzaribachev, MD, +49707129 ext. 84711, nikolay.tzaribachev@med.uni-tuebingen.de
Nikolay Tzaribachev, MD
About this study
Official title: Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment
Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement.
Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Steroid injection into the TMJs.
- Keywords
- JIA
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid injection into the TMJs.Procedure or surgery
In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.
| Study group | Role | What they receive |
|---|---|---|
| Children with JIA | Not described Receives: Procedure: Steroid injection into the TMJs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ arthritis on MRI
Measured: every three to six months from recruitment to end of study
Secondary outcomes (2)
TMJ arthritis on ultrasound
Measured: every three to six months from recruitment to end of study
Action of current medication on TMJ arthritis.
Measured: every three to six months from recruitment to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
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.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Nikolay Tzaribachev, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801593
- Sponsor's protocol ID
- TMJ PROSPECT2008
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment
- ClinicalTrials.gov ID
- NCT00801593
- Acronym / sponsor ID
- TMJ PROSPECT2008
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 3 Dec 2008 (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.
Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement.
Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with JIA | – | Procedure: Steroid injection into the TMJs. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with JIA.
Key inclusion criteria (1 listed)
- Children with defined JIA.
Key exclusion criteria (1 listed)
- Children without defined diagnosis of JIA.
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 |
|---|---|---|
| Steroid injection into the TMJs.In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance. | Procedure or surgery | Children with JIA |
Primary outcome
TMJ arthritis on MRI
Time frame: every three to six months from recruitment to end of study
2 secondary outcomes
TMJ arthritis on ultrasound
Time frame: every three to six months from recruitment to end of study
Action of current medication on TMJ arthritis.
Time frame: every three to six months from recruitment to end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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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.
Nikolay Tzaribachev, MD principal investigator
University Hospital Tuebingen
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 University Hospital Tuebingen at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2008. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolay Tzaribachev, MD (+49707129 ext. 84711, nikolay.tzaribachev@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMJ arthritis on MRI (time frame: every three to six months from recruitment to end of study). 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 3 Dec 2008.