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:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT01511003
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01511003
Study Brief:
Protocol Section:
NCT01511003