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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00891020
Eligibility Criteria:
Inclusion Criteria:
* adult patients, \>=18 years of age;
* moderate to severe active rheumatoid arthritis for \>6 months;
* inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
* Swollen joint count (SJC) \>/=4 and Tender joint count (TJC) \>/=4
* body weight \</=150kg
* current permitted non-biologic DMARDs must be on stable dose for \>/= 7 weeks prior to baseline;
Exclusion Criteria:
* history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
* treatment with rituximab within 6 months before screening;
* intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
* known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00891020
Study Brief:
Protocol Section:
NCT00891020