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)

NCT ID: NCT01511003

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-05
• Study Completion Date: 2015-05-11

Brief Summary

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus group

oral

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

oral

Interventions

Tacrolimus

oral

Intervention Type: DRUG

Other Intervention Names

Prograf

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Busan, , South Korea

Daejeon, , South Korea

Gyeonggi-do, , South Korea

Seoul, , South Korea

Countries

South Korea

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=151

Link to results on Astellas Clinical Study Results website

Other Identifiers

PRGRA-10-04-KOR

Identifier Type: -

Identifier Source: org_study_id