Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite
Not a traditional drug phase: Ultrasound for Arthritis, Rheumatoid
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 randomly assigned 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.
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Ultrasound. The registry lists allocation as randomized. 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 randomly assigned multicentre, parallel-arm clinical study Primary objective Non-inferiority of the experimental arm (i.e.
They plan to enroll about 158 people at Bruneck. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
Interventions: Ultrasound
Primary outcome (registry wording): Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy.
Who it is for (from inclusion criteria)
Ages 18 Years to 84 Years
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
No corticosteroid intraarticular injection within 4 weeks
Who the registry excludes
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"
This study wants to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters.
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05717179?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05717179?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.