The aims of this study are to assess the efficacy and safety of tacrolimus in patients with active rheumatoid arthritis(RA). EULAR(European League Against Rheumatism) response at week 24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.
A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Tacrolimus 1 mg for 0\~week4, 2mg for week4\~week8, 3mg for week8\~week24 with MTX ≤20mg/week
Kyung Hee University Hospital
Seoul, South Korea
Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
Time frame: baseline, 24weeks
Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks
Time frame: baseline, 24weeks
Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks
Time frame: baseline, 24weeks
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks
Time frame: baseline, 16weeks
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks
Time frame: baseline, 24eeks
Change from baseline C-Reactive Protein(CRP) at 16weeks
Time frame: baseline, 16weeks
Change from baseline C-Reactive Protein(CRP) at 24weeks
Time frame: baseline, 24weeks
Change from baseline European League Against Rheumatism(EULAR) response at 16weeks
Time frame: baseline, 16weeks
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