Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT01224418
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01224418
Study Brief:
Protocol Section:
NCT01224418