Rheumatoid Arthritis
Conditions
Keywords
Tacrolimus, Prograf, Calcinurin inhibitor, Rheumatoid arthritis(RA)
Brief summary
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
Interventions
DRUGTacrolimus
oral
Sponsors
Astellas Pharma Korea, Inc.
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria * Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator * ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein) * Patients are required to have at least 3 of 66 joints assessed as swollen * Patients are required to have at least 6 of 68 joints assessed as painful with pressure
Exclusion criteria
* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study * Previous experience of tacrolimus (ointment excluded) * Renal impairment or serum creatinine \> 1.4 mg/dL * Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT \> 2x upper limit normal * Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level \>110mg/dl before the meal and \>200mg/dl after the meal HbA1c \> 6.4% * Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications * Other investigational drug within last 30 days * Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 response rate compared to baseline | Baseline and up to 6 months | (ACR20: 20% improvement in American College of Rheumatology Core Set) |
Secondary
| Measure | Time frame |
|---|---|
| ACR50 response rate compared to baseline | Baseline and up to 6 months |
| ACR70 response rate compared to baseline | Baseline and up to 6 months |
| Changes from baseline in 100mm pain VAS (Visual Analogue Scale) | Baseline and up to 6 months |
| Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test | For 6 months |
Countries
South Korea
Outcome results
None listed