Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
NCT ID: NCT01394913
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2013-08-31
2014-06-30
Brief Summary
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Detailed Description
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• 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Reumatocept 25mg
50mg each week for 30 weeks
Reumatocept (etanercept)
50mg each week for 30 weeks
Enbrel 25mg
50mg each week for 30 weeks
Enbrel (etanercept)
50mg each week for 30 weeks
Interventions
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Reumatocept (etanercept)
50mg each week for 30 weeks
Enbrel (etanercept)
50mg each week for 30 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Principal Investigators
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Felipe Pinho, MD
Role: STUDY_DIRECTOR
EMS
Locations
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Associação de Assitência à Criança Deficiente
São Paulo, , Brazil
Countries
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Other Identifiers
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ETAEMS0411
Identifier Type: -
Identifier Source: org_study_id
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