Rheumatoid Arthritis Clinical Trial
Official title:
Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study
Verified date | December 2015 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
Status | Completed |
Enrollment | 78 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Korea, Inc. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR20 response rate compared to baseline | ACR20: 20% Improvement in American College of Rheumatology Core Set | Baseline and up to 6 months | No |
Secondary | ACR50 response rate compared to baseline | Baseline and up to 6 months | No | |
Secondary | ACR70 response rate compared to baseline | Baseline and up to 6 months | No | |
Secondary | Changes from baseline in 100mm pain VAS (Visual Analogue Scale) | Baseline and up to 6 months | No | |
Secondary | Changes from baseline in DAS 28 response rate | Baseline and up to 6 months | No | |
Secondary | Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test | For 6 months | No |
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