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Trial record 1 of 1 for:    NCT01262365
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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY 1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262365
First Posted: December 17, 2010
Last Update Posted: February 5, 2016
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.
Information provided by (Responsible Party):
UCB Pharma
December 14, 2010
December 17, 2010
February 5, 2016
December 2010
May 2015   (Final data collection date for primary outcome measure)
The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index [ Time Frame: Week 48 ]
The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index
Same as current
Complete list of historical versions of study NCT01262365 on ClinicalTrials.gov Archive Site
  • The percent of subjects meeting treatment response criteria at Week 24 according to a combined response index [ Time Frame: Week 24 ]
    The percent of subjects meeting treatment response criteria at Week 24 according to a combined response index
  • The percent of subjects meeting treatment response criteria at Week 12 according to a combined response index [ Time Frame: Week 12 ]
    The percent of subjects meeting treatment response criteria at Week 12 according to a combined response index
  • The percent of subjects meeting treatment response criteria at Week 36 according to a combined response index [ Time Frame: Week 36 ]
    The percent of subjects meeting treatment response criteria at Week 36 according to a combined response index
  • Change from Baseline in daily corticosteroid dose at week 24 [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in daily corticosteroid dose at week 24
  • Change from Baseline in daily corticosteroid dose at week 48 [ Time Frame: Baseline, Week 48 ]
    Change from Baseline in daily corticosteroid dose at week 48
Same as current
Not Provided
Not Provided
 
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Epratuzumab
    600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
  • Drug: Epratuzumab
    1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
  • Drug: Placebo
    Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
  • Placebo Comparator: Placebo (Weekly infusion)
    Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
    Intervention: Drug: Placebo
  • Experimental: Epratuzumab 600 mg per week
    600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
    Intervention: Drug: Epratuzumab
  • 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 four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
    Interventions:
    • Drug: Epratuzumab
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive antinuclear antibodies (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
  • Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by SLEDAI total score.
  • On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

  • Subjects who are breastfeeding, pregnant, or plan to become pregnant
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
  • Subjects with the evidence of an immunosuppressive state
  • Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
  • History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
  • Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
  • Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
  • Subjects with substance abuse or dependence or other relevant concurrent medical condition
  • Subjects with history of thromboembolic events within 1 year of screening Visit.
  • Subjects with significant hematologic abnormalities
  • Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
  • Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
  • Subject has previously participated in this study or has previously received epratuzumab treatment.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Bulgaria,   Czech Republic,   Estonia,   France,   Germany,   India,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
 
 
NCT01262365
SL0009
2010-018563-41 ( EudraCT Number )
Yes
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP