A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
- Registration Number
- NCT01511003
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tacrolimus group Tacrolimus oral
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Change in DAS28 from baseline to 6 months Baseline and at month 6 DAS (Disease Activity Score in Rheumatoid Arthritis)