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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT02833350
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for RA
* RA disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (\>=) 6 tender/painful joints on motion (68 joint count) and \>= 6 swollen joints (66 joint count) at both screening and Day 1 (randomization)
* For MTX-inadequate response (IR) participants: must have had an inadequate response to MTX
* For TNF-IR participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor
* High sensitivity C-reactive protein of \>= 0.400 milligrams per deciliter (mg/dL) for Cohort 1 and \>= 0.650 mg/dL for Cohort 2 at screening
Exclusion Criteria:
* History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
* For MTX-IR participants: History of treatment with any TNF inhibitor, including biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor for RA
* For all participants: Previous treatment with cell-depleting therapy including B cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents
* Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
* History of non-gallstone-related pancreatitis or chronic pancreatitis
* Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease
* Evidence of chronic and/or active hepatitis B or C
* Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02833350
Study Brief:
Protocol Section:
NCT02833350