Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660881
• Other study ID #: SL0008
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2008
• Last updated: July 3, 2012
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentBrazil: National Health Surveillance AgencyHong Kong: Department of HealthHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure

• Patients must have maintained eligibility requirements throughout their participation in SL0007

• Written informed consent signed prior to initiation of any study-specific assessments at visit 1

Exclusion Criteria:

• Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study

• Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures

• Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day

• Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment

• Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Epratuzumab
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Hong Kong,  Hungary,  India,  Lithuania,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)		12 Week treatment cycles	No
Secondary	The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status		Every 4 weeks through week 48, then every 12 weeks through completion	No
Secondary	The combined response index including an additional criteria involving the SF-36 response		Every 12 weeks	No
Secondary	BILAG score assessment		Every 4 weeks through week 48, then every 12 weeks through completion	No
Secondary	SLEDAI scores assessment		Every 4 weeks through week 48, then every 12 weeks through completion	No
Secondary	Patient and physician VAS		Every 4 weeks through week 48, then every 12 weeks through completion	No
Secondary	Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline		Every 12 weeks	No
Secondary	SF-36 PCS, MCS		Every 12 weeks	No
Secondary	EQ-5D results		Every 12 weeks	No
Secondary	Proportion of patients meeting treatment failure		Every 12 weeks	No
Secondary	Total daily steroid dose		Every 4 weeks for the first 48 weeks and then every 12 weeks	No
Secondary	Time to flare for patients who entered the study without flare as defined by the BILAG		over the entire course of the trial	No
Secondary	SLEDAI responder		Every 4 weeks for the first 48 weeks and then every 12 weeks	No
Secondary	Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.		over the entire course of the trial	No
Secondary	Immunogenicity as measured by human anti-human antibodies		at each dosing visit and 4 weeks post first dose of each treatment cycle	No
Secondary	Assessment of changes in baseline in levels of circulating B and T cells		The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle	No