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

Phase 3

Recruiting

• Conditions: Systemic Lupus Erythematosus; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12611000464965
• Lead Sponsor: CB, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1053

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index which incorporates criteria for achievement of responder status from the BILAG, SLEDAI, physician's global assessment of disease activity, and concomitant<br>medication.[Week 48]