Study of Epratuzumab in Systemic Lupus Erythematosus

An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Epratuzumab

Detailed Description

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Los Angeles, California, United States
    • Upland, California, United States
  • Colorado
    • Colorado Springs, Colorado, United States
    • Denver, Colorado, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Maryland
    • Baltimore, Maryland, United States
  • North Carolina
    • Durham, North Carolina, United States
  • Oklahoma
    • Tulsa, Oklahoma, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria:

• Development of toxicity to epratuzumab
• Significant protocol deviations during the SL0003 or SL0004 studies
• Evidence of significant infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epratuzumab	Biological: Epratuzumab; 360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)	From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)	From Entry Visit 1 through end of treatment (approximately 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment failure from First Visit through end of treatment (approximately 6 years)	Treatment failure is defined as initiation of a protocol specified prohibited medication.	From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
Epratuzumab plasma concentration levels at Week 0		Week 0
Epratuzumab plasma concentration levels at Week 48		Week 48
Epratuzumab plasma concentration levels at Week 96		Week 96
Epratuzumab plasma concentration levels at Week 144		Week 144
Epratuzumab plasma concentration levels at Week 192		Week 192
Epratuzumab plasma concentration levels at Week 240		Week 240
Subject Epratuzumab plasma concentration levels at Week 288		Week 288
Number of subjects with anti-epratuzumab antibody in plasma at Week 0		Week 0
Number of subjects with anti-epratuzumab antibody in plasma at Week 48		Week 48
Number of subjects with anti-epratuzumab antibody in plasma at Week 96		Week 96
Number of subjects with anti-epratuzumab antibody in plasma at Week 144		Week 144
Number of subjects with anti-epratuzumab antibody in plasma at Week 192		Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 240		Week 240
Number of subjects with anti-epratuzumab antibody in plasma at Week 288		Week 288
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score		Baseline, Last Visit
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score		Baseline, Last Visit
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)	Five point scale where 1 = very poor and 5 = very good.	Baseline, Last Visit
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)	Five point scale where 1 = very poor and 5 = very good.	Baseline, Last Visit

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 29, 2006
• First Submitted That Met QC Criteria: October 2, 2006
• First Posted (Estimate): October 3, 2006

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Lupus; Antibody; B-Cell Immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Antineoplastic Agents; Antineoplastic Agents, Immunological; Epratuzumab
• Other Study ID Numbers: SL0006; EudraCT #: 2006-004496-36