Study of Epratuzumab in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00382837
• Other study ID #: SL0005
• Secondary ID: EudraCT# 2006-00
• Status: Withdrawn
• Phase: Phase 3
• First received: September 29, 2006
• Last updated: May 20, 2014
• Start date: January 2007

Study information

• Verified date: March 2007
• 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: Ministry of HealthMexico: 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

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

• Development of toxicity to Epratuzumab

• Significant protocol deviations from SL0003 Study.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Epratuzumab

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,  Hungary,  Italy,  Netherlands,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary	To continue to assess the efficacy and tolerability of epratuzumab;
Secondary	To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Secondary	To continue to assess epratuzumab on Health-related quality of life in lupus patients;
Secondary	To continue to assess disease status as reported by the patient and physician.