Arthritis, RheumatoidUS-RA-T2TNCT05717179
Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
A study testing Ultrasound in people with Arthritis, Rheumatoid and Ultrasound, run by Italian Society for Rheumatology at 1 site in Italy.
Trial summary
Population Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) Study design Randomised multicentre, parallel-arm clinical… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Arthritis, Rheumatoid, Ultrasound, Treat to Target
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2023to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Classification of RA according to the ACR-EULAR 2010 criteria
- Age of the patients: 18 to 84 years
- Patients with moderate or high disease activity according to CDAI (>10)
- Maximum of 2 clinically swollen joints out of a 44-joint count
- Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months
- No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg/day prednisone equivalent.
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- No corticosteroid intraarticular injection within 4 weeks
- Stable or absent dose of NSAIDs for at least 1 week
- Patients able and willing to give written informed consent and compliant with the requirements of the study protocol
Who cannot join
- Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician
- Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality
- Initial arthritis manifestations before the age of 18 years
- Planned surgery within the study period for any of the joints investigated either clinically or by sonography
- Current severe medical illness requiring hospitalization
- Active infection or active malignancy at screening <5 years
- Any contraindication to b/ts DMARDs according to the "Summary of Product Characteristics"
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria dell'Alto Adige
Bruneck, Bolzano, 39031
Christian Dejaco, MD, PhD, +390474581862, Christian.Dejaco@sabes.it
About this study
Population
Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints)
Read more
Study design
Randomised multicentre, parallel-arm clinical study
Primary objective
Non-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.
Intervention
This is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or b-tsDMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms:
- Clinical decision strategy: All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator.
- Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.
Sample size
158 patients
Time plan
- Total duration of the study: 72 months
- Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit)
- Recruitment: 60 months
- Conditions
- Arthritis, Rheumatoid, Ultrasound, Treat to Target
- Being tested
- Ultrasound
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
At baseline and at weeks 12, 24 and 48, patients will undergo an ultrasound examination of 44 joints by one investigator, who is blinded to the strategic arm and all clinical data. The following joints will be assessed: bilateral wrists (distal radio-ulnar joint, radio-carpal, mid-carpal recesses), 1st - 5th MCP, 1st - 5th PIP, elbows, glenohumeral, acromioclavicular, sternoclavicular, knees, ankles and 1st - 5th MTP. At wrists, MCP and PIP joints, palmar and dorsal sites including synovial recess, extensor and flexor tendons will be investigated whereas at feet the dorsal site (plus the lateral aspects of MTP5) including synovial recess and extensor tendons will be evaluated. Further, we will assess the following: at elbows the dorsal and anterior recess, at shoulders the dorsal recess, at knees the suprapatellar as well as the medial and lateral femoro-tibial recess and at ankles the anterior, lateral and medial recess of the tibiotalar joint.
| Study group | Role | What they receive |
|---|---|---|
| Conventional decision strategy | No intervention | All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator. |
| Clinical plus ultrasound-based decision strategy | Experimental | All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy.
Non-inferiority of the experimental arm (i.e. clinical plus ultrasound-guided treatment decision) in comparison to the control arm (clinically-guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case achieving low disease activity who started from high disease activity) [19] or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.
Measured: 24 weeks
Secondary outcomes (24)
Comparison of the proportion of patients in low disease activity and MCII or remission according to ACR/EULAR index-based remission criteria at week 12 and 48
Measured: 12 and 48 weeks
Comparison of the proportion of patients in remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission, respectively) at week 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of the proportion of patients in remission according to DAS-28 (DAS-28 ≤2.6) or SDAI (≤3.3) at week 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of value of tender joints count at weeks 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of value of swollen joints counts at weeks 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) pain at weeks 12, 24 and 48
Range: 0, better outcome - 100, worse outcome
Measured: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity at weeks 12, 24 and 48
Range: 0, better outcome - 100, worse outcome
Measured: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Physician Global Assessment of Disease Activity at weeks 12, 24 and 48
Range: 0, better outcome - 100, worse outcome
Measured: 12, 24 and 48 weeks
Comparison of value of erythrocyte sedimentation rate (ESR) at weeks 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of value of C reactive protein (CRP) at weeks 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of Health assessment questionnaire (HAQ) score at week 24 and 48
Range: 0, better outcome - 3, worse outcome
Measured: 24 and 48 weeks
Comparison of Rheumatoid Arthritis Impact of Disease (RAID) score at week 24 and 48
Range: 0, better outcome - 10, worse outcome
Measured: 24 and 48 weeks
Comparison of Fatigue Assessment Scale (FAS) score at week 24 and 48
Range: 10, better outcome - 50, worse outcome
Measured: 24 and 48 weeks
Comparison of EuroQol-5 dimensions (EQ5D) score at week 24 and 48
Measured: 24 and 48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) pain across all study visits
Absolute and relative change of parameter with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity across all study visits
Absolute and relative change of parameter with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the trend of Health assessment questionnaire (HAQ) score across all study visits
Absolute and relative change of score with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the trend of Rheumatoid Arthritis Impact of Disease (RAID) score across all study visits
Absolute and relative change of score with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the trend of Fatigue Assessment Scale (FAS) score across all study visits
Absolute and relative change of score with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the trend of EuroQol-5 dimensions (EQ5D) score across all study visits
Absolute and relative change of score with respect to the baseline and between different visits
Measured: 48 weeks
Comparison of the differences in the Sharp van der Heijde Score from baseline to week 48
Range: 0, better outcome - 448, worse outcome
Measured: 48 weeks
Comparison of patients achieving a PD score of ≤1 (44-joint count) at weeks 12, 24 and 48
Measured: 12, 24 and 48 weeks
Comparison of direct medical costs of treatment arms from baseline to week 24 and 48
Measurement: Incremental cost-effectiveness ratio (ICER)
Measured: 24 and 48 weeks
Analysis regarding predictors of low disease activity or remission at 12, 24 and 48 weeks in patients treated with ≥1bDMARD as compared to those who receive pain therapy
Investigated predictors: baseline erythrocyte sedimentation rate, baseline C reactive protein, baseline ultrasound score (EULAR-OMERACT combined score)
Measured: 12, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start22 Feb 2023
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Society for Rheumatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717179
- Sponsor's protocol ID
- US-RA-T2T
- Acronym
- US-RA-T2T
- Status last verified
- Nov 2026
- First submitted
- 15 Dec 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
- ClinicalTrials.gov ID
- NCT05717179
- Acronym / sponsor ID
- US-RA-T2T / US-RA-T2T
- Conditions
- Arthritis, Rheumatoid, Ultrasound, Treat to Target
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Italian Society for RheumatologyUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 8 Feb 2023 (actual)
- 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.
Population
Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints)
Study design
Randomised multicentre, parallel-arm clinical study
Primary objective
Non-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.
Intervention
This is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) or b-tsDMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms:
- Clinical decision strategy: All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator.
- Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.
Sample size
158 patients
Time plan
- Total duration of the study: 72 months
- Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit)
- Recruitment: 60 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional decision strategy | No intervention | –All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator. |
| Clinical plus ultrasound-based decision strategy | Experimental | Diagnostic Test: UltrasoundAll patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Classification of RA according to the ACR-EULAR 2010 criteria
- Age of the patients: 18 to 84 years
- Patients with moderate or high disease activity according to CDAI (>10)
- Maximum of 2 clinically swollen joints out of a 44-joint count
- Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months
Key exclusion criteria (8 listed)
- Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician
- Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality
- Initial arthritis manifestations before the age of 18 years
- Planned surgery within the study period for any of the joints investigated either clinically or by sonography
- Current severe medical illness requiring hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAt baseline and at weeks 12, 24 and 48, patients will undergo an ultrasound examination of 44 joints by one investigator, who is blinded to the strategic arm and all clinical data. The following joints will be assessed: bilateral wrists (distal radio-ulnar joint, radio-carpal, mid-carpal recesses), 1st - 5th MCP, 1st - 5th PIP, elbows, glenohumeral, acromioclavicular, sternoclavicular, knees, ankles and 1st - 5th MTP. At wrists, MCP and PIP joints, palmar and dorsal sites including synovial recess, extensor and flexor tendons will be investigated whereas at feet the dorsal site (plus the lateral aspects of MTP5) including synovial recess and extensor tendons will be evaluated. Further, we will assess the following: at elbows the dorsal and anterior recess, at shoulders the dorsal recess, at knees the suprapatellar as well as the medial and lateral femoro-tibial recess and at ankles the anterior, lateral and medial recess of the tibiotalar joint. | Diagnostic test | Clinical plus ultrasound-based decision strategy |
Primary outcome
Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy.
Time frame: 24 weeks
Non-inferiority of the experimental arm (i.e. clinical plus ultrasound-guided treatment decision) in comparison to the control arm (clinically-guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case achieving low disease activity who started from high disease activity) [19] or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.
24 secondary outcomes
Comparison of the proportion of patients in low disease activity and MCII or remission according to ACR/EULAR index-based remission criteria at week 12 and 48
Time frame: 12 and 48 weeks
Comparison of the proportion of patients in remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission, respectively) at week 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of the proportion of patients in remission according to DAS-28 (DAS-28 ≤2.6) or SDAI (≤3.3) at week 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of tender joints count at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of swollen joints counts at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) pain at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of VAS (Visual Analogue Scale) Physician Global Assessment of Disease Activity at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of erythrocyte sedimentation rate (ESR) at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of value of C reactive protein (CRP) at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of Health assessment questionnaire (HAQ) score at week 24 and 48
Time frame: 24 and 48 weeks
Comparison of Rheumatoid Arthritis Impact of Disease (RAID) score at week 24 and 48
Time frame: 24 and 48 weeks
Comparison of Fatigue Assessment Scale (FAS) score at week 24 and 48
Time frame: 24 and 48 weeks
Comparison of EuroQol-5 dimensions (EQ5D) score at week 24 and 48
Time frame: 24 and 48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) pain across all study visits
Time frame: 48 weeks
Comparison of the trend of VAS (Visual Analogue Scale) Patient Global Assessment of Disease Activity across all study visits
Time frame: 48 weeks
Comparison of the trend of Health assessment questionnaire (HAQ) score across all study visits
Time frame: 48 weeks
Comparison of the trend of Rheumatoid Arthritis Impact of Disease (RAID) score across all study visits
Time frame: 48 weeks
Comparison of the trend of Fatigue Assessment Scale (FAS) score across all study visits
Time frame: 48 weeks
Comparison of the trend of EuroQol-5 dimensions (EQ5D) score across all study visits
Time frame: 48 weeks
Comparison of the differences in the Sharp van der Heijde Score from baseline to week 48
Time frame: 48 weeks
Comparison of patients achieving a PD score of ≤1 (44-joint count) at weeks 12, 24 and 48
Time frame: 12, 24 and 48 weeks
Comparison of direct medical costs of treatment arms from baseline to week 24 and 48
Time frame: 24 and 48 weeks
Analysis regarding predictors of low disease activity or remission at 12, 24 and 48 weeks in patients treated with ≥1bDMARD as compared to those who receive pain therapy
Time frame: 12, 24 and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Arthritis, Rheumatoid and Ultrasound, run by Italian Society for Rheumatology at 1 site in Italy.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Dejaco, MD, PhD (+390474581862, Christian.Dejaco@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy. (time frame: 24 weeks). 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 4 Nov 2026.