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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT01667458
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis, defined as DAS28 \>/= 3.7
* Inadequate clinical response to current treatment with \>/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for \>/= 3 months, or inadequate clinical response to anti-TNF therapy
* Eligible for RoActemra/Actemra treatment in daily clinical practice
* Absence of evolutive tuberculosis (TB)
Exclusion Criteria:
* Hypersensitivity to tocilizumab or any of the excipients
* Active, severe infections
* Pregnant or lactating women
* Participation in any other interventional study
* Patients with major depression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01667458
Study Brief:
Protocol Section:
NCT01667458