Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World
NCT ID: NCT03264703
Last Updated: 2020-12-16
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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COMPLETED
212 participants
OBSERVATIONAL
2017-09-11
2019-07-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with RA with cDMARD, but no anti-TNF experience
Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
* Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
* Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
1. One cDMARD plus anti-TNF
2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent
Exclusion Criteria
* Participants who have contraindication to anti-TNF
* Participants who had participated in this study
ALL
No
Sponsors
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Eisai Korea Inc.
INDUSTRY
Responsible Party
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Locations
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Eisai Trial Site # 1
Ilsan, Gyeonggi-do, South Korea
Eisai Trial Site # 1
Busan, , South Korea
Eisai Trial Site # 2
Busan, , South Korea
Eisai Trial Site # 3
Busan, , South Korea
Eisai Trial Site # 4
Busan, , South Korea
Eisai Trial Site # 1
Daegu, , South Korea
Eisai Trial Site # 2
Daegu, , South Korea
Eisai Trial Site # 1
Seoul, , South Korea
Eisai Trial Site # 2
Seoul, , South Korea
Eisai Trial Site # 3
Seoul, , South Korea
Eisai Trial Site # 4
Seoul, , South Korea
Eisai Trial Site # 5
Seoul, , South Korea
Eisai Trial Site # 6
Seoul, , South Korea
Eisai Trial Site # 7
Seoul, , South Korea
Eisai Trial Site # 8
Seoul, , South Korea
Countries
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Other Identifiers
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D2E7-M082-601
Identifier Type: -
Identifier Source: org_study_id