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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.

Official registry: https://clinicaltrials.gov/study/NCT05717179 · Italian Society for Rheumatology · enrollment listed as 158

What this phase means

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

Public study contact (from the registry)

Christian Dejaco, MD, PhD

+390474581862

Christian.Dejaco@sabes.it

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05717179 still recruiting?

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.

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