NCT00801593

Brief 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. 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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 3, 2008

Status Verified

December 1, 2008

Enrollment Period

1.6 years

First QC Date

December 2, 2008

Last Update Submit

December 2, 2008

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA

Outcome Measures

Primary Outcomes (1)

  • TMJ arthritis on MRI

    every three to six months from recruitment to end of study

Secondary Outcomes (2)

  • TMJ arthritis on ultrasound

    every three to six months from recruitment to end of study

  • Action of current medication on TMJ arthritis.

    every three to six months from recruitment to end of study

Study Arms (1)

Children with JIA

Procedure: Steroid injection into the TMJs.

Interventions

Steroid injection into the TMJs.PROCEDURE

In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.

Children with JIA

Eligibility Criteria

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

Children with JIA.

You may qualify if:

  • Children with defined JIA.

You may not qualify if:

  • Children without defined diagnosis of JIA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nikolay Tzaribachev, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolay Tzaribachev, MD

CONTACT

+49707129nikolay.tzaribachev@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

December 3, 2008

Record last verified: 2008-12

Locations

DE(1)