NCT00394238

Brief Summary

Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide distribution and can affect all age group. The peak incidence is between fourth and sixth decade. It is more prevalent in women, and it's prevalence in the general population in North America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease in families and high concordance in mono-zydotic twins support genetic predisposition. The prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown. We wish to study the link between the two conditions by performing a son graphic imaging of the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in the RA patients, further support will be landed for the link between inflammation and fatty liver disease. These findings may also have implications regarding the management and follow up of RA patients. The validity of sonographic imaging for detection of fatty liver diseases is currently accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89% and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and 89% respectively in detecting increase fibrosis. In view of all the above data, we expected to find higher prevalence of fatty liver in the patients with higher inflammation markers compare with patients with lower markers.

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 Nov 2006

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

First Submitted

Initial submission to the registry

October 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 31, 2006

Status Verified

July 1, 2006

First QC Date

October 29, 2006

Last Update Submit

October 30, 2006

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis

You may not qualify if:

  • Age below 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatoid Clinic

Jerusalem, Israel

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Michal Mates, MD

    Shaare Zedek Medical Center Jerusalem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ornit Cohen, Msc

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2006

First Posted

October 31, 2006

Study Start

November 1, 2006

Study Completion

October 1, 2008

Last Updated

October 31, 2006

Record last verified: 2006-07

Locations