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
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT03264703
- Lead Sponsor
- Eisai Korea Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
-
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
- Participants who may be pregnant or lactating women
- Participants who have contraindication to anti-TNF
- Participants who had participated in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6 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 Outcome Measures
Name Time Method Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life Up to 12 months The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.
Change from Baseline in the DAS28-ESR at Month 3 Baseline; Month 3 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.
Change from Baseline in the DAS28-ESR at Month 12 Baseline; Month 12 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.
Clinical remission rate measured by DAS28-ESR Up to 12 months Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.
Success rates of dose-reduction and discontinuation of steroid(s) Up to 12 months Dose reduction is defined as a reduction by more than 50% compared to baseline.
Trial Locations
- Locations (8)
Eisai Trial Site # 2
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 5
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 8
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 1
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 6
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 7
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 3
🇰🇷Seoul, Korea, Republic of
Eisai Trial Site # 4
🇰🇷Seoul, Korea, Republic of