Power Doppler in Hand Joints of Early RA Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Drug protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Woman with Early Rheumatoid Arthritis<br> | Drug: Drug protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Synovial blood flow (power doppler) | Measured in ultrasound examination | Baseline, after 4, 12, 24 and 48 weeks | 

Secondary Outcome Measures

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