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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01262365
First received: December 14, 2010
Last updated: September 25, 2014
Last verified: September 2014

December 14, 2010
September 25, 2014
December 2010
April 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
780
May 2015
April 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT01262365
SL0009, 2010-018563-41
Yes
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2014

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