Overview

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

Status:
Withdrawn

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

EMS

Treatments:

Etanercept

Criteria

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.