Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 3TerminatedNCT00111306

UCB Pharma510 enrolled

Overview

The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

510

Conditions

Systemic Lupus Erythematosus

Interventions

epratuzumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has SLE by ACR revised criteria (meets \<4 criteria); * Has SLE with at least one elevated lupus antibody; * Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic Exclusion Criteria: * Active severe CNS or Renal disease defined by BILAG as Level A * Allergy to murine or human antibodies * Antiphospholid antibodies AND a history of thrombocytopenic events

Locations (18)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.

Secondary Outcomes

Proportion of patients with complete response or partial response;

Individual BILAG assessments;

Physician and patient assessment scores;

Time-to treatment failure;

Successful steroid reduction by weeks 20 and 24;

Maintenance of steroid reduction at 24 and 48 weeks;

Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;

Assess epratuzumab on Health-related quality of life.

Data from ClinicalTrials.gov

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