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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01683695
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
* Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
* Other inclusion criteria may apply.
Exclusion Criteria:
* Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
* Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
* Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
* Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
* Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
* Other exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01683695
Study Brief:
Protocol Section:
NCT01683695