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Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01408576
First received: August 1, 2011
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of subjects prematurely discontinuing due to a treatment-emergent adverse event (TEAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ]
    A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

  • Number of subjects reporting at least 1 serious adverse event (SAE) during the treatment period (maximum 96 weeks) [ Time Frame: During the treatment period (through Week 96) ]

    A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

    • Death
    • Life-threatening
    • Significant or persistent disability/incapacity
    • Congenital anomaly/birth defect (including that occurring in a fetus)
    • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
    • Initial inpatient hospitalization or prolongation of hospitalization


Secondary Outcome Measures:
  • The percent of subjects meeting treatment response criteria according to a combined response index [ Time Frame: Week 48 ]
    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

  • The percent of subjects meeting treatment response criteria according to a combined response index [ Time Frame: Week 96 ]
    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.


Enrollment: 1253
Study Start Date: July 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Drug: Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Experimental: Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Drug: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

Detailed Description:
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
  Eligibility

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

Inclusion Criteria:

  • Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
  • Substance abuse or dependence
  • History of malignant cancer
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
  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: NCT01408576

  Show 228 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01408576     History of Changes
Other Study ID Numbers: SL0012
2010-020859-30 ( EudraCT Number )
Study First Received: August 1, 2011
Last Updated: March 14, 2016

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

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

ClinicalTrials.gov processed this record on June 23, 2017