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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT00714116
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology \[ACR\] Revised Criteria) greater than 6 months before study day 1.
* History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.
Exclusion Criteria:
* Treatment with more than 20 mg of prednisone per day.
* Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
* History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00714116
Study Brief:
Protocol Section:
NCT00714116