Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
