Back to resultsComparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Reumatocept (etanercept)
Enbrel (etanercept)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
- Patients with at least 6 swollen joints
- Patients with partial response in treatment with methotrexate for 2 months
Exclusion Criteria:
- Pregnancy and Lactation
- Patients with uncontrolled hypertension
- Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
- Non-steroidal anti-inflammatory drug in the last 4 weeks
- Any pathology or past medical condition that can interfere with this protocol
- Patients with immunodeficiency and/or immunosuppressive disease;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Sites / Locations
- Associação de Assitência à Criança Deficiente
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reumatocept 25mg
Enbrel 25mg
Arm Description
50mg each week for 30 weeks
50mg each week for 30 weeks
Outcomes
Primary Outcome Measures
Efficacy
Health Assessment Questionnaire (HAQ)
Disease Activity Score (DAS28)
Clinical Disease Activity Index (CDAI)
American College of Rheumatology criteria (ACR)
Visual Activity Schedule(VAS)
Secondary Outcome Measures
Safety
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394913
Brief Title
Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
Official Title
A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reumatocept 25mg
Arm Type
Experimental
Arm Description
50mg each week for 30 weeks
Arm Title
Enbrel 25mg
Arm Type
Active Comparator
Arm Description
50mg each week for 30 weeks
Intervention Type
Drug
Intervention Name(s)
Reumatocept (etanercept)
Intervention Description
50mg each week for 30 weeks
Intervention Type
Drug
Intervention Name(s)
Enbrel (etanercept)
Intervention Description
50mg each week for 30 weeks
Primary Outcome Measure Information:
Title
Efficacy
Description
Health Assessment Questionnaire (HAQ)
Disease Activity Score (DAS28)
Clinical Disease Activity Index (CDAI)
American College of Rheumatology criteria (ACR)
Visual Activity Schedule(VAS)
Time Frame
day 1 to day 210
Secondary Outcome Measure Information:
Title
Safety
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
day 1 to day 210
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
Patients with at least 6 swollen joints
Patients with partial response in treatment with methotrexate for 2 months
Exclusion Criteria:
Pregnancy and Lactation
Patients with uncontrolled hypertension
Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
Non-steroidal anti-inflammatory drug in the last 4 weeks
Any pathology or past medical condition that can interfere with this protocol
Patients with immunodeficiency and/or immunosuppressive disease;
Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Pinho, MD
Organizational Affiliation
EMS
Official's Role
Study Director
Facility Information:
Facility Name
Associação de Assitência à Criança Deficiente
City
Sao Paulo
ZIP/Postal Code
04038004
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
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