Early Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGDrug 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.
Sponsors
Federal University of São Paulo
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Synovial blood flow (power doppler) | Baseline, after 4, 12, 24 and 48 weeks | Measured in ultrasound examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Tenosynovitis | Baseline, after 4, 12, 24 and 48 weeks | Measured in ultrasound examination |
| Changes in Joint Damage | 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 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 |
| Changes in disease activity score | Baseline, after 4, 12, 24 and 48 weeks | Measured by disease activity score 28 |
| Changes in erythrocyte sedimentation rate level (mm/hour) | Baseline, after 4, 12, 24 and 48 weeks | Measured in blood test |
Outcome results
None listed