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

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

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Reumatocept (etanercept); Drug: Enbrel (etanercept)

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04038004
    • Associação de Assitência à Criança Deficiente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reumatocept 25mg; 50mg each week for 30 weeks	Drug: Reumatocept (etanercept); 50mg each week for 30 weeks
Active Comparator: Enbrel 25mg; 50mg each week for 30 weeks	Drug: Enbrel (etanercept); 50mg each week for 30 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: ETAEMS0411