NCT01394913

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Reumatocept (etanercept)	50mg each week for 30 weeks
DRUG	Enbrel (etanercept)	50mg each week for 30 weeks

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2011-07-15
• Last updated: 2021-02-24

Locations

1 site across 1 country: Brazil