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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00688103
Eligibility Criteria:
Inclusion Criteria:
* Patients had to be at least 18 years of age
* fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)
* met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints
* either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)
* be ACR functional class I-III
* have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
Exclusion Criteria:
* Patients who required concurrent use of prednisone (PSL) \>10 mg/day, or its equivalent, were excluded from study entry
* the start of dose increment of PSL equivalents within 3 months of the study enrollment
* experience of antirheumatic therapy except for MTX and PSL equivalents
* previous treatment with ETN or any other biological treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00688103
Study Brief:
Protocol Section:
NCT00688103