Study of Epratuzumab in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00111306
• Other study ID #: SL0003 (IMMU-103-03)
• Secondary ID: EudraCT #: 2005-
• Status: Terminated
• Phase: Phase 3
• First received: May 19, 2005
• Last updated: November 7, 2011
• Start date: June 2005
• Est. completion date: March 2007

Study information

• Verified date: November 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Ministry of Social Affairs, Public Health and the 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: National Institute of Public Health, Health SecretariatNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 510
• 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:

• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Hungary,  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.