Power Doppler in Hand Joints of Early RA Patients

Federal University of São Paulo

Status: Completed

Conditions: Early Rheumatoid Arthritis

Treatments: Drug: Drug protocol

Study type: Observational

Funder types: Other

Identifiers

NCT04752748

106108

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
• age between 18-65 years;
• female gender,
• naive for treatment.

Exclusion criteria

• use of oral > 10 mg/d glucocorticoid in the previous three weeks;
• serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal;
• bone marrow, auto-imune, lymphoproliferative or infectious diseases;
• pregnancy.

Trial design

48 participants in 1 patient group

Woman with Early Rheumatoid Arthritis

Treatment:

Drug: Drug protocol