NCT01261793 - Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) | Crick

Overview

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

791

Conditions

Systemic Lupus Erythematosus

Interventions

PlaceboDRUG

Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

EpratuzumabDRUG

600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles

EpratuzumabDRUG

1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (133)

Outcomes

Primary Outcomes

The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index

Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.

Time frame: At Week 48

Secondary Outcomes

The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index

Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.

Time frame: At Week 24

The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index

Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.