Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach

Recruiting now · Not applicable

Conditions studied: Arthritis, Rheumatoid, Ultrasound, Treat to Target

In brief

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: 1. 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. 2. 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

Key facts

Study ID: NCT05717179
Run by: Italian Society for Rheumatology
People needed: 158
Starts: 2023-02-22
Expected to finish: 2029-02-01
Last updated by the study team: 2025-05-14

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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

Where it is running

Azienda Sanitaria dell'Alto Adige — Bruneck, Bolzano, Italy (enrolling)

Full record on ClinicalTrials.gov

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