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

Phase 3

Withdrawn

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Reumatocept (etanercept); Drug: Enbrel (etanercept)

• Registration Number: NCT01394913
• Lead Sponsor: EMS

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

Study Timeline

• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Study Start: 2013-08
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reumatocept 25mg	Reumatocept (etanercept)	50mg each week for 30 weeks
Enbrel 25mg	Enbrel (etanercept)	50mg each week for 30 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety	day 1 to day 210	Adverse events will be collected and followed in order to evaluate safety and tolerability

Trial Locations

Locations (1)

Associação de Assitência à Criança Deficiente; 🇧🇷 Sao Paulo, Brazil