Status:
COMPLETED
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
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
Brief Summary
This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 month...
Eligibility Criteria
Inclusion
- Diagnosed with rheumatoid arthritis within 3 years
- 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:
- One cDMARD plus anti-TNF
- Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent
Exclusion
- Participants who may be pregnant or lactating women
- Participants who have contraindication to anti-TNF
- Participants who had participated in this study
Key Trial Info
Start Date :
September 11 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT03264703
Start Date
September 11 2017
End Date
July 17 2019
Last Update
December 16 2020
Active Locations (15)
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1
Eisai Trial Site # 1
Ilsan, Gyeonggi-do, South Korea
2
Eisai Trial Site # 1
Busan, South Korea
3
Eisai Trial Site # 2
Busan, South Korea
4
Eisai Trial Site # 3
Busan, South Korea