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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


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
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