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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02720120
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe RA for at least 6 months
* Positive serum rheumatoid factor (\>/= 20 international units per milliliter)
* Current treatment with RA on an outpatient basis
* Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate
* Current treatment with methotrexate for at least 12 weeks, at a stable dose
* Use of highly effective contraception.
Exclusion Criteria:
* Rheumatic autoimmune disease or inflammatory joint disease, other than RA
* Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy
* Treatment with any other investigational drug within 4 weeks of screening
* Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening
* Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent
* History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies
* Known active bacterial, viral or fungal infections
* History of active tuberculosis and primary or secondary immunodeficiency
* History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02720120
Study Brief:
Protocol Section:
NCT02720120