Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383214
• Other study ID #: SL0004(IMMU-103-04)
• Secondary ID: EudraCT #: 2005-
• Status: Terminated
• Phase: Phase 3
• First received: September 29, 2006
• Last updated: June 6, 2012
• Start date: May 2005
• Est. completion date: March 2007

Study information

• Verified date: June 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentBrazil: Ministry of HealthCanada: Health CanadaChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutHong Kong: Department of HealthHungary: National Institute of PharmacyIndia: Ministry of HealthItaly: The Italian Medicines AgencyMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• +ANA at screening

• BILAG Index B Level Activity in at least 2 body systems/organs

• Has SLE by ACR revised criteria (meets,<4 criteria)

Exclusion Criteria:

• Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.

• Allergy to human antibodies or Murine.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion

Other:
• Placebo
Intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Secondary	Proportion of patients with complete response or partial response;
Secondary	Individual BILAG assessments;
Secondary	Physician and patient assessment scores;
Secondary	Time-to treatment failure;
Secondary	Successful steroid reduction by weeks 20 and 24;
Secondary	Maintenance of steroid reduction at 24 and 48 weeks;
Secondary	Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Secondary	Assess epratuzumab on Health-related quality of life