An Observational 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 ["HUMAN" Study]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis, Rheumatoid
- Sponsor
- Eisai Korea Inc.
- Enrollment
- 212
- Locations
- 8
- Primary Endpoint
- Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Participants who may be pregnant or lactating women
- •Participants who have contraindication to anti-TNF
- •Participants who had participated in this study
Outcomes
Primary Outcomes
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
Time Frame: Baseline; Month 6
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Secondary Outcomes
- Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life(Up to 12 months)
- Change from Baseline in the DAS28-ESR at Month 3(Baseline; Month 3)
- Change from Baseline in the DAS28-ESR at Month 12(Baseline; Month 12)
- Clinical remission rate measured by DAS28-ESR(Up to 12 months)
- Success rates of dose-reduction and discontinuation of steroid(s)(Up to 12 months)