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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01463059
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
* Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR \>28mm/hour
* Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
* Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Exclusion Criteria:
* Have a diagnosis of any other inflammatory arthritis
* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
* Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
* Subjects with known concurrent acute or chronic viral hepatitis B or C infection
* Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
* Subjects with known history of or current clinically active infection
* Subjects at high risk of infection
* Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
* Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
* Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01463059
Study Brief:
Protocol Section:
NCT01463059