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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00660881
First received: April 15, 2008
Last updated: July 3, 2012
Last verified: July 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • The combined response index including an additional criteria involving the SF-36 response [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • BILAG score assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ] [ Designated as safety issue: No ]
  • SLEDAI scores assessment [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ] [ Designated as safety issue: No ]
  • Patient and physician VAS [ Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion ] [ Designated as safety issue: No ]
  • Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • SF-36 PCS, MCS [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • EQ-5D results [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients meeting treatment failure [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Total daily steroid dose [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • SLEDAI responder [ Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks ] [ Designated as safety issue: No ]
  • Time to sustained response for patients entering SL0008 with flare as defined by the BILAG. [ Time Frame: over the entire course of the trial ] [ Designated as safety issue: No ]
  • Immunogenicity as measured by human anti-human antibodies [ Time Frame: at each dosing visit and 4 weeks post first dose of each treatment cycle ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00660881     History of Changes
Other Study ID Numbers: SL0008, EudraCT Number: 2007-002589-37
Study First Received: April 15, 2008
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health

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

ClinicalTrials.gov processed this record on September 22, 2014