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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01224041
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus group	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
ACR20 response rate compared to baseline	Baseline and up to 6 months	ACR20: 20% Improvement in American College of Rheumatology Core Set

Secondary Outcome Measures

Name	Time	Method
ACR70 response rate compared to baseline	Baseline and up to 6 months
ACR50 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