Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.

Detailed Description
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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

Official Title
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A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Reumatocept (etanercept)
* Drug: Enbrel (etanercept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria; Patients with at least 6 swollen joints Patients with partial response in treatment with methotrexate for 2 months Exclusion Criteria: Pregnancy and Lactation Patients with uncontrolled hypertension Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis Non-steroidal anti-inflammatory drug in the last 4 weeks Any pathology or past medical condition that can interfere with this protocol Patients with immunodeficiency and/or immunosuppressive disease; Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reumatocept 25mg<br>50mg each week for 30 weeks | Drug: Reumatocept (etanercept)<br>* 50mg each week for 30 weeks<br>|
| Active Comparator: Enbrel 25mg<br>50mg each week for 30 weeks | Drug: Enbrel (etanercept)<br>* 50mg each week for 30 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Health Assessment Questionnaire (HAQ) Disease Activity Score (DAS28) Clinical Disease Activity Index (CDAI) American College of Rheumatology criteria (ACR) Visual Activity Schedule(VAS) | day 1 to day 210 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events will be collected and followed in order to evaluate safety and tolerability | day 1 to day 210 |