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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01219933
Eligibility Criteria:
Inclusion Criteria:
Non-interventional phase
* Adult patients, \>/=18 years of age
* Moderate to severe active rheumatoid arthritis defined as Disease Activity Score using 28-joint count (DAS28) \>/=5.1
* Patients with inadequate clinical response to a current treatment with 2 or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of them being methotrexate (MTX) optimally administered during a period of more than 3 months or inadequate response to a current anti-TNF therapy
* Current use of oral glucocorticoids started at least 4 weeks prior to enrolment Interventional phase
* Patients enrolled in the non-interventional phase
* Patients with low disease activity defined as DAS28 \</=3.2 at Visit 2
* Use of oral glucocorticoids with methylprednisolone equivalent dose of \>/=1mg and \</=20mg/day at Visit 2
Exclusion Criteria:
Non-interventional \& interventional phase
* Rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis
* Prior history or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01219933
Study Brief:
Protocol Section:
NCT01219933