This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.
Study design: • Double blinded, non-inferiority, prospective parallel-group, intend to treat trial. Study design: * Experiment duration: 30 weeks * 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210) * Health Assessment Questionnaire (HAQ) evaluation * Disease Activity Score (DAS28) evaluation * Clinical Disease Activity Index (CDAI) evaluation * American College of Rheumatology criteria (ACR) evaluation * Visual Activity Schedule(VAS) evaluation * Adverse events evaluation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
50mg each week for 30 weeks
50mg each week for 30 weeks
Associação de Assitência à Criança Deficiente
São Paulo, Brazil
Efficacy
1. Health Assessment Questionnaire (HAQ) 2. Disease Activity Score (DAS28) 3. Clinical Disease Activity Index (CDAI) 4. American College of Rheumatology criteria (ACR) 5. Visual Activity Schedule(VAS)
Time frame: day 1 to day 210
Safety
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: day 1 to day 210
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