Rheumatoid Arthritis
Conditions
Keywords
calcineurin inhibitor, Prograf, Rheumatoid arthritis (RA), Tacrolimus
Brief summary
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria * Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer * Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL * Subjects with ≥ 3 swollen joints out of 66 joints assessed * Subjects with ≥ 6 tender joints out of 68 joints assessed
Exclusion criteria
* Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out * Subjects with previous experience of tacrolimus (excluding external preparations) * Subjects with renal dysfunction or with serum creatinin \> 1.4 mg/dL at screening * Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening * Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c \> 6.4% at screening * Subjects complicated with hyperkalemia or with serum potassium level \>5.5 mEq/L at screening * Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications * Subjects complicated with severe respiratory disease and infection * Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.) * Subjects who were treated with other investigational product(s) within 3 months before screening * Other subjects who are considered ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 response rate 6 months post dose | Baseline and 6 months post dose | ACR20 is 20% improvement in ACR (American College of Rheumatology) core set |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR50 response rates at month 6 | Baseline and at month 6 | ACR50 is 50% improvement in ACR (American College of Rheumatology) core set |
| ACR70 response rates at month 6 | Baseline and at month 6 | ACR70 is 70% improvement in ACR (American College of Rheumatology) core set |
| Change in DAS28 from baseline to 6 months | Baseline and at month 6 | DAS (Disease Activity Score in Rheumatoid Arthritis) |
| Change in bone loss rate from baseline to 6 months | Baseline and at month 6 | comparative factors for bone loss rate: bone mineral densitometry \[BMD\], bone turnover marker test |
| Safety assessed by the incidence of adverse events, vital signs and lab-tests | For 6 months | — |
Countries
South Korea
Outcome results
None listed