Power Doppler in Hand Joints of Early RA Patients

Completed

• Conditions: Early Rheumatoid Arthritis
• Interventions: Drug: Drug protocol

• Registration Number: NCT04752748
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2021-02
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Woman with Early Rheumatoid Arthritis	Drug protocol	-

Primary Outcome Measures

Name	Time	Method
Changes in Synovial blood flow (power doppler)	Baseline, after 4, 12, 24 and 48 weeks	Measured in ultrasound examination

Secondary Outcome Measures

Name	Time	Method
Changes in Tenosynovitis	Baseline, after 4, 12, 24 and 48 weeks	Measured in ultrasound examination
Changes in C-reactive protein level (mg/liter)	Baseline, after 4, 12, 24 and 48 weeks	Measured in blood test
Change in Synovial Proliferation	Baseline, after 4, 12, 24 and 48 weeks	Measured in ultrasound examination
Changes in erythrocyte sedimentation rate level (mm/hour)	Baseline, after 4, 12, 24 and 48 weeks	Measured in blood test
Changes in disease activity score	Baseline, after 4, 12, 24 and 48 weeks	Measured by disease activity score 28
Changes in Joint Damage	Baseline, after 4, 12, 24 and 48 weeks	Measured in ultrasound examination
Changes in function	Baseline, after 4, 12, 24 and 48 weeks	Measured by Health Assessment Questionnaire
Changes in upper limb function	Baseline, after 4, 12, 24 and 48 weeks	Measured by Disabilities of the Arm, Shoulder and Hand Questionnaire