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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262365
Other study ID # SL0009
Secondary ID 2010-018563-41
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2010
Est. completion date May 2015

Study information

Verified date June 2018
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 793
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Czechia,  Estonia,  France,  Germany,  India,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. At Week 48
Secondary The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. At Week 24
Secondary The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. At Week 12
Secondary The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. At Week 36
Secondary Change From Baseline in Daily Corticosteroid Dose at Week 24 Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit. At Week 24
Secondary Change From Baseline in Daily Corticosteroid Dose at Week 48 Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit. At Week 48
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