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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01911234
Eligibility Criteria:
Inclusion Criteria:
* Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al. 2010) for at least 6 months.
* Has been treated with and tolerated MTX for at least 3 months prior to the first administration of study product, - Has at least four swollen joints/66 and/or four tender joints/68,
* Has CRP ≥ 10 mg/L at screening.
* Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.
Exclusion Criteria:
* Has inflammatory rheumatic disease other than RA
* Has been treated with non-biological DMARDs/systemic immunosuppressives
* Has been treated with leflunomide within 12 weeks prior to first administration of study product.
* Has received intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids
* Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
* Has been treated with any other biological DMARDs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01911234
Study Brief:
Protocol Section:
NCT01911234