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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT02638259
Eligibility Criteria:
Inclusion Criteria:
* Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \>/= 6 months at the time of baseline visit
* Patient must have active disease defined as DAS28-CRP\>/=3.2
* Patients must have CRP level above ULN \>5mg/l) or erythrocyte sedimentation rate (ESR) \>/=28mm/h
* Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards
Exclusion Criteria:
* Previous exposure to etanercept in the past
* Patients with functional status class IV according to the ACR 1991 revised criteria
* History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02638259
Study Brief:
Protocol Section:
NCT02638259