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

Launched by ITALIAN SOCIETY FOR RHEUMATOLOGY · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether using ultrasound technology to guide treatment decisions can help patients with rheumatoid arthritis (RA) achieve better disease control compared to standard clinical decision-making. The study focuses on adults aged 18 to 84 who have been diagnosed with RA and are experiencing moderate to high disease activity despite being on stable medication for at least three months. To be eligible, participants must have no more than two swollen joints out of a total of 44 and must not have previously received certain biological treatments for RA.

Participants in the trial will be randomly assigned to one of two groups. One group will receive treatment based solely on clinical evaluations, while the other group will have their treatment decisions guided by ultrasound assessments that check for inflammation in their joints. Both groups will start with a medication called a TNF-alpha blocker and may switch to other treatments if their condition does not improve in 12 weeks. The entire study will take about 42 months to complete, and participants can expect to be involved for about 48 weeks. This research aims to determine which approach is more effective in helping patients reach a state of low disease activity or remission.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Classification of RA according to the ACR-EULAR 2010 criteria
• • 2. Age of the patients: 18 to 84 years
• • 3. Patients with moderate or high disease activity according to CDAI (\>10)
• • 4. Maximum of 2 clinically swollen joints out of a 44-joint count
• • 5. Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months
• • 6. No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg/day prednisone equivalent.
• • 7. No corticosteroid intraarticular injection within 4 weeks
• • 8. Stable or absent dose of NSAIDs for at least 1 week
• • 9. Patients able and willing to give written informed consent and compliant with the requirements of the study protocol
• Exclusion Criteria:
• • 1. Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician
• • 2. 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
• • 3. Initial arthritis manifestations before the age of 18 years
• • 4. Planned surgery within the study period for any of the joints investigated either clinically or by sonography
• • 5. Current severe medical illness requiring hospitalization
• • 6. Active infection or active malignancy at screening \<5 years
• • 7. Any contraindication to b/ts DMARDs according to the "Summary of Product Characteristics"
• • 8. Pregnancy or lactation