Arthritis, Rheumatoid Clinical Trial
Official title:
Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
Population Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI>10) despite conventional synthetic (cs)DMARD(s) therapy for ≥3 months, naïve to biological (b) and targeted synthetic (ts)DMARDs therapy 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) therapy for ≥3 months, naïve to biological (b) and targeted synthetic (ts)DMARDs therapy 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 TNF-alpha blocker while continuing background csDMARD(s) therapy. 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 TNF-alpha blocker while continuing 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 csDMARD(s) will be continued. Sample size 110 patients Time plan - Total duration of the study: 42 months - Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit) - Recruitment: 30 months
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