NCT04752748

Power Doppler in Hand Joints of Early RA Patients

Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.

Conditions

• Early Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Drug protocol	The following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score\> 3.2 and the Physician's Global Assessment (PGA)\> 4.0 \[0-10 cm\]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks: * Failure 1: failure of the first DMARD (MTX) in week 12. * Failure 2: failure of the second DMARD (leflunomide) at week 24 * Failure 3: failure of the first immunobiological (adalimumab) at week 48.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2021-02-12
• Last updated: 2021-02-17