Rheumatoid Arthritis3D sono in RANCT00858169
Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography
An observational study of Rheumatoid Arthritis, run by Taichung Veterans General Hospital.
Trial summary
The purpose of this study is to: 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Taichung Veterans General Hospital
The purpose of this study is to:
- 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)
- 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- three-dimensional power Doppler ultrasonography, wrist, knee, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TCVGH, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858169
- Sponsor's protocol ID
- C09044
- Acronym
- 3D sono in RA
- Status last verified
- Feb 2015
- First submitted
- 6 Mar 2009
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taichung Veterans General Hospital
- ClinicalTrials.gov ID
- NCT00858169
- Acronym / sponsor ID
- 3D sono in RA / C09044
- Conditions
- Rheumatoid Arthritis
- Keywords
- three-dimensional power Doppler ultrasonography, wrist, knee, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Mar 2009 (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.
The purpose of this study is to:
- 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)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
Time frame: cross-sectional
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 13 Feb 2015.
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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 Rheumatoid Arthritis, run by Taichung Veterans General Hospital.
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 3 inclusion and 4 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 13 Feb 2015. 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?
Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) (time frame: cross-sectional). 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 13 Feb 2015.