Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624351
• Other study ID #: SL0007
• Secondary ID: 2007-002566-35
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2008
• Last updated: September 2, 2011
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: 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 HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive ANA result at visit 1

• Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met

• Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present

• If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.

Exclusion Criteria:

• Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.

Other:
• Placebo
Phosphate-buffered Saline (PBS) infusion.

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	Response at Week 12 according to a combined response index	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.	Week 12	No
Secondary	Response at Week 4 according to a combined response index	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.	Week 4	No
Secondary	Response at Week 8 according to a combined response index	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.	Week 8	No
Secondary	Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.	Week 4	No
Secondary	Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.	Week 8	No
Secondary	Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response	The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.	Week 12	No
Secondary	Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4		Baseline, Week 4	No
Secondary	Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8		Baseline, Week 8	No
Secondary	Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12		Baseline, Week 12	No
Secondary	Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24		Baseline, Week 24	No
Secondary	Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12		Baseline, Week 12	No
Secondary	Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2		Baseline, Week 2	No
Secondary	Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4		Baseline, Week 4	No
Secondary	Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8		Baseline, Week 8	No
Secondary	Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12		Baseline, Week 12	No
Secondary	Change from baseline in physician global assessment at Week 12		Baseline, Week 12	No
Secondary	Change from baseline in patient global assessment at Week 12		Baseline, Week 12	No
Secondary	Short Form-36 (SF-36) response at Week 2	SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores.	Baseline, Week 2	No
Secondary	Short Form-36 (SF-36) response at Week 4	SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores	Baseline, Week 4	No
Secondary	Short Form-36 (SF-36) response at Week 8	SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores	Baseline, Week 8	No
Secondary	Short Form-36 (SF-36) response at Week 12	SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores	Baseline, Week 12	No
Secondary	European Quality of Life-5 Dimensions (EQ-5D) score at Week 12		Week 12	No
Secondary	Time to first sustained British Isles Lupus Assessment Group (BILAG) response		From Baseline to Week 12	No
Secondary	Time to enhanced British Isles Lupus Assessment Group (BILAG) response		From Baseline to Week 12	No
Secondary	Treatment failure up to Week 12	Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.	From Baseline to Week 12	No
Secondary	Cumulative steroid dose at Week 12		From Baseline to Week 12	No
Secondary	Human anti-human antibodies (HAHA) levels at Week 12		Week 12	No
Secondary	Change from baseline in levels of circulating B cells at Week 12		Baseline, Week 12	No
Secondary	Change from baseline in levels of circulating T cells at Week 12		Baseline, Week 12	No