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

Study Overview
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Brief Summary
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This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus group<br> | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response rate compared to baseline | ACR20: 20% Improvement in American College of Rheumatology Core Set | Baseline and up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 response rate compared to baseline |  | Baseline and up to 6 months | 
| ACR70 response rate compared to baseline |  | Baseline and up to 6 months | 
| Changes from baseline in 100mm pain VAS (Visual Analogue Scale) |  | Baseline and up to 6 months | 
| Changes from baseline in DAS 28 response rate |  | Baseline and up to 6 months | 
| Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test |  | For 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Prograf, Calcinurin inhibitor, Rheumatoid arthritis (RA)