48
Participants
Start Date
August 31, 2014
Primary Completion Date
August 31, 2015
Study Completion Date
August 31, 2016
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."
Federal University of São Paulo
OTHER