Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

UCB Pharma227 enrolled

Overview

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

227

Conditions

Systemic Lupus Erythematosus

Interventions

EpratuzumabBIOLOGICAL

Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.

PlaceboOTHER

Phosphate-buffered Saline (PBS) infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Positive ANA result at visit 1 * Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met * Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present * If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry. Exclusion Criteria: * Patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study * Active severe SLE disease activity which involves the central nervous system (CNS) (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures * Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher World Health Organization (WHO) nephritis) or serum creatinine \>2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day * Patients with a history of anti-phospholipid antibody syndrome AND use of oral anticoagulants or anti-platelet treatment * Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection

Locations (53)

Outcomes

Primary Outcomes

Response at Week 12 according to a combined response index

The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.

Time frame: Week 12

Secondary Outcomes

Response at Week 4 according to a combined response index

Time frame: Week 4

Response at Week 8 according to a combined response index

Time frame: Week 8

Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response

Time frame: Week 4

Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

La Jolla, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

San Leandro, California, United States

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Farmington, Connecticut, United States

Unnamed facility

Aventura, Florida, United States

Unnamed facility

Tampa, Florida, United States

Unnamed facility

Baltimore, Maryland, United States

...and 43 more locations

Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response

Time frame: Week 12

Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4

Time frame: Baseline, Week 4

Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8

Time frame: Baseline, Week 8

Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12

Time frame: Baseline, Week 12

Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24

Time frame: Baseline, Week 24

Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12

Time frame: Baseline, Week 12

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2

Time frame: Baseline, Week 2

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4

Time frame: Baseline, Week 4

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8

Time frame: Baseline, Week 8

Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12

Time frame: Baseline, Week 12

Change from baseline in physician global assessment at Week 12

Time frame: Baseline, Week 12

Change from baseline in patient global assessment at Week 12

Time frame: Baseline, Week 12

Short Form-36 (SF-36) response at Week 2

SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores.

Time frame: Baseline, Week 2

Short Form-36 (SF-36) response at Week 4

SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores

Time frame: Baseline, Week 4

Short Form-36 (SF-36) response at Week 8

SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores

Time frame: Baseline, Week 8

Short Form-36 (SF-36) response at Week 12

SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores

Time frame: Baseline, Week 12

European Quality of Life-5 Dimensions (EQ-5D) score at Week 12

Time frame: Week 12

Time to first sustained British Isles Lupus Assessment Group (BILAG) response

Time frame: From Baseline to Week 12

Time to enhanced British Isles Lupus Assessment Group (BILAG) response

Time frame: From Baseline to Week 12

Treatment failure up to Week 12

Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.

Time frame: From Baseline to Week 12

Cumulative steroid dose at Week 12

Time frame: From Baseline to Week 12

Human anti-human antibodies (HAHA) levels at Week 12

Time frame: Week 12

Change from baseline in levels of circulating B cells at Week 12

Time frame: Baseline, Week 12

Change from baseline in levels of circulating T cells at Week 12

Time frame: Baseline, Week 12