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Completed

NCT Number: NCT01408576

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

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

429, Camperdown, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epratuzumab

Drug

600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles

Primary outcomes

  1. 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.

  2. Percentage 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.

  3. 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

  4. Percentage 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 outcomes

  1. Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

    Time frame: At 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.

  2. Percentage 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.

  3. Number 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

Acronym: EMBODY4

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2011
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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