Status:
COMPLETED
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01224041
Start Date
August 1 2009
End Date
June 1 2011
Last Update
December 29 2015
Active Locations (5)
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1
Busan, South Korea
2
Daegu, South Korea
3
Gwangju, South Korea
4
Jeonju, South Korea