Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach (US-RA-T2T)
Arthritis, Rheumatoid, Ultrasound, Treat to Target
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria: 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 a combination thereof 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 Exclusion Criteria: Previous or current treatment with any b/ts DMARD 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
Sites / Locations
- Azienda Sanitaria dell'Alto AdigeRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Clinical decision strategy
Clinical plus ultrasound-based 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.
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.