A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

• Status: Completed
• Trial end date: 2015-05-11
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Antirheumatic Agents; Tacrolimus

Criteria

Inclusion Criteria:

• Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria

• Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer

• Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL

• Subjects with ≥ 3 swollen joints out of 66 joints assessed

• Subjects with ≥ 6 tender joints out of 68 joints assessed

Exclusion Criteria:

• Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out

• Subjects with previous experience of tacrolimus (excluding external preparations)

• Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening

• Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening

• Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening

• Subjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening

• Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications

• Subjects complicated with severe respiratory disease and infection

• Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)

• Subjects who were treated with other investigational product(s) within 3 months before screening

• Other subjects who are considered ineligible for the study by the investigator