Disorders of Synovium, Multiple SitesNCT01476865
Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients
An observational study of Disorders of Synovium, Multiple Sites and Disorders of Subchondral Bone, Multiple Sites, run by Federal University of São Paulo.
Trial summary
The purpose of this study is to establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorders of Synovium, Multiple Sites, Disorders of Subchondral Bone, Multiple Sites, Disorders of Cartilage, Hand Joints
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jun 2011
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)
Who may be able to join
- no articular disease (healthy group)
- establish rheumatoid arthritis (RA group)
Who cannot join
- diabetes
- hypothyroidism- hemophilia
- pregnancy
- previous septic arthritis
- previous articular surgery
- symptomatic osteoarthritis
- no superimposed collagenoses (RA group)
About this study
Official title: Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients
The purpose of this study is to establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory, systemic and auto-imune disorder affecting primarily the joints. In RA, inflammatory synovium causes destruction of cartilage, erosion of the adjacent bone and ultimately loss of function of the affected joint. Newer imaging techniques, such as ultrasound (US), have shown promise in evaluation of RA. Many US scoring system have been used to classify and quantify the synovium, effusion, erosion and cartilage for assessing and monitoring AR. However, its use is considered problematical because there are very few data on normal joints and, at this point, there is no clear definition of excess amount of synovium in normal people.
- Conditions
- Disorders of Synovium, Multiple Sites, Disorders of Subchondral Bone, Multiple Sites, Disorders of Cartilage, Hand Joints, Arthritis, Rheumatoid, Healthy People
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | normal, healthy people | |
| RA | rheumatoid arthritis patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Synovium, Multiple SitesStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, FLAVIA SOARES MACHADO, Federal University of São Paulo
- Investigators
- Jamil Natour, professor, Study chair, Federal University of São PauloRita NV Furtado, PhD, Study chair, Federal University of São PauloFlávia S Machado, master, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476865
- Sponsor's protocol ID
- 1295/09
- Status last verified
- Nov 2011
- First submitted
- 18 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01476865
- Acronym / sponsor ID
- 1295/09
- Conditions
- Disorders of Synovium, Multiple Sites, Disorders of Subchondral Bone, Multiple Sites, Disorders of Cartilage, Hand Joints, Arthritis, Rheumatoid, Healthy People
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Nov 2011 (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 establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory, systemic and auto-imune disorder affecting primarily the joints. In RA, inflammatory synovium causes destruction of cartilage, erosion of the adjacent bone and ultimately loss of function of the affected joint. Newer imaging techniques, such as ultrasound (US), have shown promise in evaluation of RA. Many US scoring system have been used to classify and quantify the synovium, effusion, erosion and cartilage for assessing and monitoring AR. However, its use is considered problematical because there are very few data on normal joints and, at this point, there is no clear definition of excess amount of synovium in normal people.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –normal, healthy people |
| RA | – | –rheumatoid arthritis patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)
Key inclusion criteria (2 listed)
- no articular disease (healthy group)
- establish rheumatoid arthritis (RA group)
Key exclusion criteria (7 listed)
- diabetes
- hypothyroidism- hemophilia
- pregnancy
- previous septic arthritis
- previous articular surgery
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
Not reported in the source record.
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 22 Nov 2011.
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.
Jamil Natour, professor study chair
Federal University of São Paulo
Rita NV Furtado, PhD study chair
Federal University of São Paulo
Flávia S Machado, master principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Synovium, Multiple Sites and Disorders of Subchondral Bone, Multiple Sites, run by Federal University of São Paulo.
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 2 inclusion and 7 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 22 Nov 2011. 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.
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 22 Nov 2011.