We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00383513
Previous Study | Return to List | Next Study

Study of Epratuzumab in Systemic Lupus Erythematosus

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.
 
ClinicalTrials.gov Identifier: NCT00383513
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Epratuzumab Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : June 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) ]
  2. 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 Outcome Measures :
  1. 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.

  2. Epratuzumab plasma concentration levels at Week 0 [ Time Frame: Week 0 ]
  3. Epratuzumab plasma concentration levels at Week 48 [ Time Frame: Week 48 ]
  4. Epratuzumab plasma concentration levels at Week 96 [ Time Frame: Week 96 ]
  5. Epratuzumab plasma concentration levels at Week 144 [ Time Frame: Week 144 ]
  6. Epratuzumab plasma concentration levels at Week 192 [ Time Frame: Week 192 ]
  7. Epratuzumab plasma concentration levels at Week 240 [ Time Frame: Week 240 ]
  8. Subject Epratuzumab plasma concentration levels at Week 288 [ Time Frame: Week 288 ]
  9. Number of subjects with anti-epratuzumab antibody in plasma at Week 0 [ Time Frame: Week 0 ]
  10. Number of subjects with anti-epratuzumab antibody in plasma at Week 48 [ Time Frame: Week 48 ]
  11. Number of subjects with anti-epratuzumab antibody in plasma at Week 96 [ Time Frame: Week 96 ]
  12. Number of subjects with anti-epratuzumab antibody in plasma at Week 144 [ Time Frame: Week 144 ]
  13. Number of subjects with anti-epratuzumab antibody in plasma at Week 192 [ Time Frame: Week 192 ]
  14. Number of subjects with anti-epratuzumab antibody in plasma at Week 240 [ Time Frame: Week 240 ]
  15. Number of subjects with anti-epratuzumab antibody in plasma at Week 288 [ Time Frame: Week 288 ]
  16. Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Last Visit ]
  17. Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score [ Time Frame: Baseline, Last Visit ]
  18. 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.

  19. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00383513


Locations
Layout table for location information
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Upland, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Maryland
Baltimore, Maryland, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00383513    
Other Study ID Numbers: SL0006
EudraCT #: 2006-004496-36
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by UCB Pharma:
Lupus
Antibody
B-Cell Immunotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents