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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660881
First Posted: April 17, 2008
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Condition Intervention Phase
Systemic Lupus Erythematosus Biological: Epratuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits) [ Time Frame: 12 Week treatment cycles ]

Secondary Outcome Measures:
  • The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
  • The combined response index including an additional criteria involving the SF-36 response [ Time Frame: Every 12 weeks ]
  • BILAG score assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
  • SLEDAI scores assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
  • Patient and physician VAS [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ]
  • Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline [ Time Frame: Every 12 weeks ]
  • SF-36 PCS, MCS [ Time Frame: Every 12 weeks ]
  • EQ-5D results [ Time Frame: Every 12 weeks ]
  • Proportion of patients meeting treatment failure [ Time Frame: Every 12 weeks ]
  • Total daily steroid dose [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ]
  • Time to flare for patients who entered the study without flare as defined by the BILAG [ Time Frame: over the entire course of the trial ]
  • SLEDAI responder [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ]
  • Time to sustained response for patients entering SL0008 with flare as defined by the BILAG. [ Time Frame: over the entire course of the trial ]
  • Immunogenicity as measured by human anti-human antibodies [ Time Frame: at each dosing visit and 4 weeks post first dose of each treatment cycle ]
  • Assessment of changes in baseline in levels of circulating B and T cells [ Time Frame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle ]

Enrollment: 210
Study Start Date: May 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMAB
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660881


  Show 42 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00660881     History of Changes
Other Study ID Numbers: SL0008
EudraCT Number: 2007-002589-37
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-Cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases