- Rheumatoid ArthritisNCT01639287
Painless Synovitis in Patients With Longstanding Rheumatoid Arthritis
An observational study of - Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- - Rheumatoid Arthritis
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jul 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Federal University of São Paulo ambulatory (Unifesp) and basic helth unit
Who may be able to join
- longstanding rheumatoid arthritis
- chronically painless synovitis in the hands or painful
Who cannot join
- uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
- change of basic drug in the last 3 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04023900
Daniele Pereira, 55 11 96088707, danisfreitas22@yahoo.com.br
About this study
Official title: Correlation of "Painless" Synovitis With Clinical, Laboratory and Radiological (X-ray, Sonography) Finds in Patients With Longstanding Rheumatoid Arthritis (RA).
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands.
The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings.
A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.
Read the detailed description
Introduction/Objectives:
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion.
The objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings, articular damage (x-Ray and sonography), clinical, laboratory and demographic variables in RA patients.
Methods: Cross-sectional study with RA patients, which will be evaluated metacarpophalangeal joints of patients without local painful. Sixty RA patients will be selected in the Federal University of São Paulo ambulatory (Unifesp). The patients will be divided in two groups of thirty patients each: "painless synovitis" Group and "painful synovitis" Group. All patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, ESR; rheumatoid factor, RF; anti-cyclic-citrullinated peptide antibodies, CCP) on the same day. The clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). This measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (VAS 0-10); swollen VAS; activity disease VAS; measurement of grip strength and pinch with Jamar dynamometer and Preston Pinch Gauge; 28 joint Disease Activity Score (DAS 28); Stanford Health Assessment Questionnaire (HAQ); Cochin Hand Functional Scale (CHFS) and patient clinical evaluation. The level of statistical significance will be 5%.
- Conditions
- - Rheumatoid Arthritis
- 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 |
|---|---|---|
| Painless | Painless synovitis group(called "cold" synovitis) | |
| Painful | Painful synovitis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic power Doppler
Measured: baseline
Secondary outcomes (1)
Sonographic Gray Scale
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
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, Daniele Freitas Pereira, Federal University of São Paulo
- Investigators
- Daniele F Pereira, Dr, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639287
- Sponsor's protocol ID
- USG-3131-AR
- Status last verified
- Jul 2012
- First submitted
- 10 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of "Painless" Synovitis With Clinical, Laboratory and Radiological (X-ray, Sonography) Finds in Patients With Longstanding Rheumatoid Arthritis (RA).
- ClinicalTrials.gov ID
- NCT01639287
- Acronym / sponsor ID
- USG-3131-AR
- Conditions
- - Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 12 Jul 2012 (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.
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands.
The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings.
A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.
Detailed description
Introduction/Objectives:
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion.
The objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings, articular damage (x-Ray and sonography), clinical, laboratory and demographic variables in RA patients.
Methods: Cross-sectional study with RA patients, which will be evaluated metacarpophalangeal joints of patients without local painful. Sixty RA patients will be selected in the Federal University of São Paulo ambulatory (Unifesp). The patients will be divided in two groups of thirty patients each: "painless synovitis" Group and "painful synovitis" Group. All patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, ESR; rheumatoid factor, RF; anti-cyclic-citrullinated peptide antibodies, CCP) on the same day. The clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). This measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (VAS 0-10); swollen VAS; activity disease VAS; measurement of grip strength and pinch with Jamar dynamometer and Preston Pinch Gauge; 28 joint Disease Activity Score (DAS 28); Stanford Health Assessment Questionnaire (HAQ); Cochin Hand Functional Scale (CHFS) and patient clinical evaluation. The level of statistical significance will be 5%.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painless | – | –Painless synovitis group(called "cold" synovitis) |
| Painful | – | –Painful synovitis group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Federal University of São Paulo ambulatory (Unifesp) and basic helth unit
Key inclusion criteria (2 listed)
- longstanding rheumatoid arthritis
- chronically painless synovitis in the hands or painful
Key exclusion criteria (2 listed)
- uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
- change of basic drug in the last 3 months
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
Sonographic power Doppler
Time frame: baseline
1 secondary outcome
Sonographic Gray Scale
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
Daniele F Pereira, Dr principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of - Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniele F Pereira (+55 11 96088607, danisfreits22@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic power Doppler (time frame: baseline). 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 12 Jul 2012.