None listed
Conditions
Interventions
Drug : Patients in the treatment group are treated with tacrolimus for 24 weeks. The initial dose is 1.5 mg one capsule a day and increased to 3 mg/day after 4 weeks(Visit 3). Depending on the physici
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 80 years 2. Patients fulfilling the 2010 ACR/EULAR classification criteria for rheumatoid arthritis 3. Treated methotrexate (= 7.5mg/week) for more than 12 weeks before Baseline 4. DAS score(CRP criterion) = 3.2 at Screening and Baseline 5. If a patient is childbearing age of female, she should consent to continue contraception until 12 weeks after completion of the study. 6. If a patient is male, he should consent to continue contraception along with his female partner until 12 weeks after the completion of the study. 7. Patients who understand about the study, and provided informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of allergic reaction to study medication 2. Patients who have other inflammatory arthritis (ex. psoriatic arthritis, ankylosing spondylitis or reactive arthritis) 3. Patients who have been treated with or using the following medications at visit 2(Baseline) -Analgesics: Treated within 24 hours of clinical evaluation -Non-biologic DMARDs: Treated within 28 days or 5 times of half-life of inclusion(except Methotrexate) Patients who have been treated unsuccessfully in the past with leflunomide, tacrolimus or cyclosporine due to adverse effect or refractoriness. -Biologic DMARDs: Patients who have used biologic DMARDs in the past. -IM/IV/IA Corticosteroids, IA hyaluronic acid: Treated within 28 days. -NSAIDs/ COX-2 Inhibitors: Changed dose within 14 days. -Oral Corticosteroids: Changed dose within 28 days of inclusion. Daily dose exceeds 10mg of prednisolone or equivalent steroid dose. 4. Pregnant or breast-feeding patients. Patients who plan conception or breast-feeding during the study and within 12 weeks after completion of the study 5. Patients who have abnormal blood count (ex. leucopenia, thrombocytopenia or hemoglobin less than 9 g/dL) 6. Patients with chronic infectious disease or history of severe infectious disease within 24 weeks of Baseline 7. Patients who received live attenuated vaccination within 8 weeks of Baseline 8. Patients who are infected with HIV 9. Patients who were diagnosed lymphoma/lymphoproliferative disorder or have clinical features that suggest these diseases. 10. Patients who have a cancer or have a history of malignancy (patients who have history of treated malignancy more than 5 years before screening can be included) 11. Patients who had a history of severe and/or uncontrolled disease involving kidney, liver, hematologic system, GI system, endocrine system, lung, heart or nervous system within 24 weeks of Baseline. 12. Patients with New York Heart Association (NYHA) class III or IV congestive heart failure. 13. Patients who was diagnosed with a systemic inflammatory disorder (ex. systemic lupus erythematosus, systemic sclerosis or mixed connective disorder) 14. Hepatitis B virus surface antigen (HBsAg) positive and/or anti-hepatitis C virus (HCVAb) positive patient 15. Patients who had a history of CNS disease, demyelinating disorder or seizure disorder. 16. Patients who plan to get surgery during the study period. 17. Alcohol or drug abuser 18. Patients who have chronic pancreatitis or uncontrolled diabetes/hypertension. 19. Patients who have at least one of following laboratory abnormalities at Screening and Baseline. 1) WBC 1.5mg/dL 6) AST or ALT > more than 1.5 times of upper normal value of clinical laboratory. 20. Patients who received medication for a clinical trial within 30 days of screening. 21. Patients who are uncooperative or unable to follow procedures during the study period. 22. Patients who is thought to ineligible for this trial according to investigator’s judgement.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Outcome: DAS(Disease Activity Score) 28 score, KHAQ(Korean Health Assessment Questionnaire) score, Tender joint count 68 score, Swollen joint count 66 score;Safety Outcome: Adverse events, Abnormal findings in vital signs, Laboratory tests | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome: DAS(Disease Activity Score) 28 score | — |
Countries
Korea, Republic of
Contacts
Public ContactKichul Shin
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed