Status:
COMPLETED
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)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2015
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01511003
Start Date
December 5 2011
End Date
May 11 2015
Last Update
August 13 2018
Active Locations (4)
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1
Busan, South Korea
2
Daejeon, South Korea
3
Gyeonggi-do, South Korea
4
Seoul, South Korea