Using ultrasound to guide treatment decisions for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Christian Dejaco, MD, PhD
• Email: Christian.Dejaco@sabes.it
• Phone: +390474581862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.