Rheumatoid Arthritis
Conditions
Brief summary
This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.
Detailed description
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
Interventions
DRUGReumatocept (etanercept)
50mg each week for 30 weeks
50mg each week for 30 weeks
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be able to understand the study procedures agree to participate and give written consent. 2. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria; 3. Patients with at least 6 swollen joints 4. Patients with partial response in treatment with methotrexate for 2 months
Exclusion criteria
1. Pregnancy and Lactation 2. Patients with uncontrolled hypertension 3. Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis 4. Non-steroidal anti-inflammatory drug in the last 4 weeks 5. Any pathology or past medical condition that can interfere with this protocol 6. Patients with immunodeficiency and/or immunosuppressive disease; 7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | day 1 to day 210 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | day 1 to day 210 | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Countries
Brazil
Outcome results
None listed