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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01261793
Eligibility Criteria:
Inclusion Criteria:
* Positive antinuclear antibodies (ANA) at Screening (Visit 1)
* Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
* Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
* Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
* On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
Exclusion Criteria:
* Subjects who are breastfeeding, pregnant, or plan to become pregnant
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
* Subjects with the evidence of an immunosuppressive state
* Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
* History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
* Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
* Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
* Subjects with substance abuse or dependence or other relevant concurrent medical condition
* Subjects with history of thromboembolic events within 1 year of screening Visit.
* Subjects with significant hematologic abnormalities
* Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
* Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
* Subject has previously participated in this study or has previously received epratuzumab treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01261793
Study Brief:
Protocol Section:
NCT01261793