Study of Epratuzumab in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00383513
First received: September 29, 2006
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 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: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as safety issue: No ]
    Treatment failure is defined as initiation of a protocol specified prohibited medication.

  • Epratuzumab plasma concentration levels at Week 0 [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Epratuzumab plasma concentration levels at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Epratuzumab plasma concentration levels at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Epratuzumab plasma concentration levels at Week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Epratuzumab plasma concentration levels at Week 192 [ Time Frame: Week 192 ] [ Designated as safety issue: No ]
  • Epratuzumab plasma concentration levels at Week 240 [ Time Frame: Week 240 ] [ Designated as safety issue: No ]
  • Subject Epratuzumab plasma concentration levels at Week 288 [ Time Frame: Week 288 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 0 [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 192 [ Time Frame: Week 192 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 240 [ Time Frame: Week 240 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-epratuzumab antibody in plasma at Week 288 [ Time Frame: Week 288 ] [ Designated as safety issue: No ]
  • Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Last Visit ] [ Designated as safety issue: No ]
  • Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score [ Time Frame: Baseline, Last Visit ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA) [ Time Frame: Baseline, Last Visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Five point scale where 1 = very poor and 5 = very good.


Enrollment: 29
Study Start Date: June 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epratuzumab Biological: Epratuzumab
360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00383513

Locations
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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00383513     History of Changes
Other Study ID Numbers: SL0006, EudraCT #: 2006-004496-36
Study First Received: September 29, 2006
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lupus
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 August 26, 2014