Study of Epratuzumab in Systemic Lupus Erythematosus

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2012

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).

Interventions

  • Biological: Epratuzumab
    • 360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

Arms, Groups and Cohorts

  • Experimental: Epratuzumab

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
    • Time Frame: 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)
    • Time Frame: From Entry Visit 1 through end of treatment (approximately 6 years)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

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