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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01617005
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria)
* Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
* Initiating treatment with tocilizumab according to SPC
Exclusion Criteria:
* Rheumatic autoimmune disease other than RA
* Prior history or current inflammatory joint disease other than RA
* Previous treatment with any biological drug used in the treatment of RA
* Previous treatment with tocilizumab
* Any contraindication to treatment with tocilizumab
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Pregnant women or nursing (breastfeeding) mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01617005
Study Brief:
Protocol Section:
NCT01617005