Using ultrasound to guide treatment decisions for rheumatoid arthritis

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

This study is testing if using ultrasound to help make treatment choices can be just as good as regular methods for people with rheumatoid arthritis who are still having symptoms despite their current treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 84 Years
• Sex: All
• Sponsor: Italian Society for Rheumatology (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Bruneck, Bolzano)
• Trial ID: NCT05717179 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of using ultrasound to guide treatment decisions in patients with rheumatoid arthritis (RA) who have moderate to high disease activity despite existing therapies. It is a randomized multicenter study comparing ultrasound-guided treatment decisions to standard clinical decision-making. The primary goal is to determine if the ultrasound approach is non-inferior in helping patients achieve low disease activity or remission within 24 weeks. Eligible participants include those with specific disease activity levels and treatment histories.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 84 with moderate or high disease activity in rheumatoid arthritis and a maximum of two swollen joints.

Not a fit: Patients with complete joint destruction or those with active systemic manifestations of rheumatoid arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with rheumatoid arthritis.

How similar studies have performed: Other studies have shown promise in using ultrasound for treatment decisions in rheumatoid arthritis, suggesting this approach may be effective.

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

Where this trial is running

Bruneck, Bolzano

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

Study contacts

• Study coordinator: Christian Dejaco, MD, PhD

Conditions Arthritis, Rheumatoid; Ultrasound; Treat to Target