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:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT01262365

First received: December 14, 2010

Last updated: January 12, 2016

Last verified: January 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2010

Last Updated Date

January 12, 2016

Start Date ^ICMJE

December 2010

Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01262365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Official Title ^ICMJE

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

Brief Summary

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Lupus Erythematosus

Intervention ^ICMJE

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

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

793

Completion Date

May 2015

Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01262365

Other Study ID Numbers ^ICMJE

SL0009
2010-018563-41 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

UCB Pharma

Study Sponsor ^ICMJE

UCB Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCb Clinical Trial Call Center

+1 877 822 9493 (UCB)

PRS Account

UCB Pharma

Verification Date

January 2016

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

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