Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 780

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 SLEDAI total score.
- On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 740
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 received epratuzumab treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.;Secondary Objective: The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment.;Primary end point(s): The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index. ;Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) The percent of subjects meeting treatment response criteria at Week 24, according to the combined index. <br>b) The percent of subjects meeting treatment response criteria at Week 12, according to the combined index. <br>c) The percent of subjects meeting treatment response criteria at Week 36, according to the combined index. <br>d) Change from Baseline in daily corticosteroid dose at Week 24<br>e) Change from Baseline in daily corticosteroid dose at Week 48<br>;Timepoint(s) of evaluation of this end point: a) 24 weeks<br>b) 12 weeks<br>c) 36 weeks<br>d) Baseline - 24 weeks<br>e) Baseline - 48 weeks

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