Overview

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Korea, Inc.
Treatments:
Methotrexate
Tacrolimus
Criteria
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