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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: November 24, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Epratuzumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 780
Study Start Date: December 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Drug: Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
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
Drug: Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 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 four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01262365

  Hide Study Locations
Locations
United States, Alabama
069
Birmingham, Alabama, United States
United States, Arkansas
063
Little Rock, Arkansas, United States
United States, California
085
Escondido, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
074
San Diego, California, United States
80
San Gabriel, California, United States
United States, Colorado
048
Aurora, Colorado, United States
037
Colorado Springs, Colorado, United States
United States, Connecticut
039
Farmington, Connecticut, United States
United States, Florida
042
Aventura, Florida, United States
090
Clearwater, Florida, United States
092
Debary, Florida, United States
064
Jupiter, Florida, United States
082
Miami, Florida, United States
070
Ormond Beach, Florida, United States
084
Palm Harbor, Florida, United States
062
Tamarac, Florida, United States
050
Tampa, Florida, United States
087
Vero Beach, Florida, United States
United States, Georgia
044
Lawrenceville, Georgia, United States
United States, Illinois
052
Chicago, Illinois, United States
United States, Indiana
096
Indianapolis, Indiana, United States
United States, Louisiana
060
Shreveport, Louisiana, United States
United States, Maryland
040
Baltimore, Maryland, United States
United States, Michigan
047
St Clair Shores, Michigan, United States
United States, New Mexico
067
Las Cruces, New Mexico, United States
United States, New York
053
New York, New York, United States
United States, North Carolina
077
Charlotte, North Carolina, United States
058
Durham, North Carolina, United States
United States, Ohio
061
Columbus, Ohio, United States
071
Middleburg Heights, Ohio, United States
United States, Oklahoma
041
Oklahoma City, Oklahoma, United States
076
Oklahoma City, Oklahoma, United States
097
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
032
Duncansville, Pennsylvania, United States
093
Philadelphia, Pennsylvania, United States
073
Pittsburgh, Pennsylvania, United States
094
Pittsburgh, Pennsylvania, United States
United States, South Carolina
099
Charleston, South Carolina, United States
001
Columbia, South Carolina, United States
034
Simpsonville, South Carolina, United States
United States, Tennessee
057
Memphis, Tennessee, United States
United States, Texas
098
Austin, Texas, United States
078
Austin, Texas, United States
079
Dallas, Texas, United States
055
Houston, Texas, United States
036
Mesquite, Texas, United States
066
San Antonio, Texas, United States
Australia, Queensland
426
Maroochydore, Queensland, Australia
Australia, Victoria
425
Malvern, Victoria, Australia
Australia
429
Camperdown, Australia
427
Clayton, Australia
430
Liverpool, Australia
Belgium
106
Brussels, Belgium
107
Brussels, Belgium
105
Leuven, Belgium
104
Liege, Belgium
Brazil
455
Campinas, Brazil
453
Porto Alegre, Brazil
451
Recife, Brazil
450
Rio de Janeiro, Brazil
452
Salvador, Brazil
454
Sao Paulo, Brazil
Bulgaria
201
Plovdiv, Bulgaria
205
Sofia, Bulgaria
200
Sofia, Bulgaria
202
Sofia, Bulgaria
204
Sofia, Bulgaria
203
Sofia, Bulgaria
Czech Republic
218
Olomouc, Czech Republic
216
Praha 2, Czech Republic
215
Zlin, Czech Republic
Estonia
226
Tallinn, Estonia
France
113
Lille, France
114
Nantes, France
112
Paris, France
116
Pessac, France
115
Sibilia, France
Germany
127
Berlin, Germany
128
Frankfurt, Germany
126
Freiburg, Germany
130
Hannover, Germany
129
Plochingen, Germany
India
351
Bangalore, India
352
Hyderabad, India
350
Lucknow, India
Israel
378
Ashkelon, Israel
376
Beer Sheva, Israel
375
Haifa, Israel
377
Haifa, Israel
381
Jerusalem, Israel
382
Kfar Saba, Israel
380
Rehovot, Israel
379
Tel Aviv, Israel
383
Tel-Hashomer, Israel
Italy
149
Ferrara, Italy
148
Padova, Italy
147
Torino, Italy
Korea, Republic of
306
Busan, Korea, Republic of
303
Daegu, Korea, Republic of
309
Daegu, Korea, Republic of
308
Daejeon, Korea, Republic of
300
Gangnam-Gu, Korea, Republic of
304
Incheon, Korea, Republic of
310
Jeonju, Korea, Republic of
301
Jung-gu, Korea, Republic of
307
Seoul, Korea, Republic of
302
Suwon, Korea, Republic of
Lithuania
156
Klaipeda, Lithuania
155
Pileckyte, Lithuania
Mexico
480
Gaudalajara, Mexico
475
Guadalajara, Mexico
476
Guadalajara, Mexico
478
Guadalajara, Mexico
Puerto Rico
091
Cidra, Puerto Rico
086
San Juan, Puerto Rico
Romania
263
Brasov, Romania
264
Bucharest, Romania
262
Bucharest, Romania
260
Bucharest, Romania
261
Cluj-Napoca, Romania
Russian Federation
281
Ekaterinburg, Russian Federation
285
Petrozavodsk, Russian Federation
284
Saint Petersburg, Russian Federation
Spain
165
La Laguna, Santa Cruz de Tenerife, Spain
164
Bilbao, Vizcaya, Spain
161
Barcelona, Spain
162
Madrid, Spain
163
Madrid, Spain
166
Malaga, Spain
177
Santander, Spain
160
Sevilla, Spain
Taiwan
325
Changhua, Taiwan
326
Dalin-Town, Taiwan
328
Kaohsiung County, Taiwan
329
Taichung, Taiwan
330
Taipei, Taiwan
United Kingdom
178
Brighton, United Kingdom
182
Doncaster, United Kingdom
179
Leeds, United Kingdom
181
Romford, United Kingdom
180
Sheffield, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01262365     History of Changes
Other Study ID Numbers: SL0009, 2010-018563-41
Study First Received: December 14, 2010
Last Updated: November 24, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014