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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01394913
• Other study ID #: ETAEMS0411
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Reumatocept (etanercept)
50mg each week for 30 weeks
• Enbrel (etanercept)
50mg each week for 30 weeks

Locations

Country	Name	City	State
Brazil	Associação de Assitência à Criança Deficiente	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety	Adverse events will be collected and followed in order to evaluate safety and tolerability	day 1 to day 210