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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT01149057
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/=18 years of age
* Active moderate to severe rheumatoid arthritis
* Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic)
* Current treatment at stable dose for \>/=8 weeks
* Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion
Exclusion Criteria:
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV (American College of Rheumatology Classification)
* Prior history or current inflammatory joint disease other than RA
* Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent
* Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
* Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
* History of or currently active primary or secondary immunodeficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149057
Study Brief:
Protocol Section:
NCT01149057