NCT00858169

Brief Summary

The purpose of this study is to:

  1. 1.To investigate the wrist joint synovial blood flow intensity and model by quantitative three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid arthritis before and after initiation of a new medicine and compare these data with routinely used clinical data and laboratory findings, such as pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
  2. 2.To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS assessment of the vascularity in wrist joints and knee joints using automatic volume scan.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

March 6, 2009

Last Update Submit

February 12, 2015

Conditions

Keywords

three-dimensional power Doppler ultrasonographywristkneerheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)

    cross-sectional

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 30 patients with RA who visit outpatient clinic of Rheumatology at Taichung Veterans General Hospital (TCVGH) will be enrolled consecutively at if they met the study inclusion criteria

You may qualify if:

  • Patients who fulfill the 1987 ARA criteria for RA
  • Patients with at least one painful swollen wrist or knee joint observed by a rheumatologist
  • Patients who will receive a new medicine, including oral corticosteroid, intravenous methylprednisolone pulse therapy, intraarticular injection with steroid or methotrexate, DMARDs, or biologic agent

You may not qualify if:

  • Patients with active infection
  • Patients with concurrent malignant disease
  • Patients with a history of traumatic, septic, or cystal arthritis, previous joint surgery, or arthroscopic synovectomy of any wrist or kneejoint within the past 12 months before the study
  • Patients who have severe wrist or knee joint deformity that makes the US assessment protocol unable to complete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taichung Veterans General Hospital

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 13, 2015

Record last verified: 2015-02