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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT03605251
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
* Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.
* Have an inadequate response to MTX
* Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count
* Have hsCRP of ≥ 0.6 mg/dL
Exclusion Criteria:
* Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
* Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment
* Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors
* Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening
* Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents
* Have a diagnosis of Felty's syndrome
* Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening
* Have a positive result of β-D-glucan at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT03605251
Study Brief:
Protocol Section:
NCT03605251