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The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ā„10 despite on-going stable corticosteroid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blisibimod weekly dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blisibimod | Drug | blisibimod administered via subcutaneous injection every week for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving an SLE Responder Index at week 52 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first severe SLE flare | Week 52 | |
| Proportion of subjects able to reduce oral steroid dose to ā¤7.5 mg/day prednisone | Week 52 | |
| Change in the number of actively tender or swollen joints and in mucocutaneous disease activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 603 | Homyel | 246029 | Belarus | |||
| Investigator Site 604 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29563108 | Derived | Merrill JT, Shanahan WR, Scheinberg M, Kalunian KC, Wofsy D, Martin RS. Phase III trial results with blisibimod, a selective inhibitor of B-cell activating factor, in subjects with systemic lupus erythematosus (SLE): results from a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2018 Jun;77(6):883-889. doi: 10.1136/annrheumdis-2018-213032. Epub 2018 Mar 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 10, 2018 | |
| Reset | May 10, 2018 | |
| Release | Jul 17, 2018 |
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| Placebo | Drug | Placebo will be administered weekly via subcutaneous injection for 52 weeks |
|
| Week 52 |
| Change in proteinuria from baseline | Week 52 |
| Proportion of subjects with improved patient-reported outcomes | Week 52 |
| Time to treatment failure | Week 52 |
| Time to first renal flare | Week 52 |
| Change from baseline in B cell subsets, anti dsDNA, C3, C4 | Week 52 |
| Safety Profile (AEs, vital signs, labs, physical exams) | Week 52 |
| Minsk |
| 220037 |
| Belarus |
| Investigator Site 601 | Minsk | 220116 | Belarus |
| Investigator Site 605 | Minsk | 223040 | Belarus |
| Investigator Site 602 | Vitebsk | 210037 | Belarus |
| Investigator Site 558 | Curitiba | Brazil |
| Investigator Site 555 | Goiânia | 74110-120 | Brazil |
| Investigator Site 557 | Juiz de Fora | 36010-570 | Brazil |
| Investigator Site 551 | Porto Alegre | 90610-000 | Brazil |
| Investigator Site 559 | Santo AndrƩ | Brazil |
| Investigator Site 554 | SĆ£o Paulo | 04032-060 | Brazil |
| Investigator Site 556 | SĆ£o Paulo | 13015-001 | Brazil |
| Investigator Site 302 | Antioquia | Colombia |
| Investigator Site 303 | Antioquia | Colombia |
| Investigator Site 308 | AtlƔntico | Colombia |
| Investigator Site 310 | AtlƔntico | Colombia |
| Investigator Site 301 | BogotĆ” | Colombia |
| Investigator Site 311 | BogotĆ” | Colombia |
| Investigator Site 304 | Cundinamarca | Colombia |
| Investigator Site 305 | Santander | Colombia |
| Investigator Site 306 | Santander | Colombia |
| Investigator Site 312 | Valle | Colombia |
| Investigator Site 001 | Tbilisi | 0102 | Georgia |
| Investigator Site 002 | Tbilisi | 0186 | Georgia |
| Investigator Site 003 | Tbilisi | 0186 | Georgia |
| Investigator Site 901 | Guatemala City | 01010 | Guatemala |
| Investigator Site 902 | Guatemala City | 01011 | Guatemala |
| Investigator Site 903 | Guatemala City | Guatemala |
| Investigator Site 904 | Guatemala City | Guatemala |
| Investigator Site 151 | Pokfulam | Hong Kong |
| Investigator Site 152 | Tuenmen | Hong Kong |
| Investigator Site 503 | Ahmedabad | 382428 | India |
| Investigator Site 508 | Bangalore | 560034 | India |
| Investigator Site 505 | Hyderabad | 500 082 | India |
| Investigator Site 502 | Hyderabad | 500 096 | India |
| Investigator Site 501 | Kolkata | 700054 | India |
| Investigator Site 506 | Manipal | 576 104 | India |
| Investiagtor Site 513 | Mumbai | 400053 | India |
| Investigator Site 511 | New Delhi | 110 060 | India |
| Investigator Site 512 | New Delhi | 110 076 | India |
| Investigator Site 504 | Pune | 411 001 | India |
| Investigator Site 510 | Pune | 411007 | India |
| Investigator Site 251 | Kuala Selangor | Malaysia |
| Investigator Site 252 | Perak | Malaysia |
| Investigator Site 702 | Guanajuato City | 37000 | Mexico |
| Investigator Site 703 | Mexico City | 07760 | Mexico |
| Investigator Site 701 | Mexico City | 14000 | Mexico |
| Investigator Site 704 | Mexico City | 97133 | Mexico |
| Investigator Site 707 | Toluca | 50120 | Mexico |
| Investigator Site 705 | YucatƔn | 97133 | Mexico |
| Investigator Site 407 | Angeles | 2009 | Philippines |
| Investigator Site 404 | Cebu City | 6000 | Philippines |
| Investigator Site 406 | Cebu City | 6000 | Philippines |
| Investigator Site 408 | Cruz Manila | 1003 | Philippines |
| Investigator Site 405 | Davao City | 8000 | Philippines |
| Investigator Site 402 | Ermita, Manila | 1000 | Philippines |
| Investigator Site 410 | Iloilo City | 5000 | Philippines |
| Investigator Site 401 | Las PiƱas | 1742 | Philippines |
| Investigator Site 403 | Manila | 1008 | Philippines |
| Investigator Site 409 | Manila | Philippines |
| Investigator Site 052 | Kemerovo | 650000 | Russia |
| Investigator Site 053 | Kemerovo | 650029 | Russia |
| Investigator Site 054 | Kursk | 305007 | Russia |
| Investigator Site 051 | Moscow | Russia |
| Investigator Site 058 | Novosibirsk | 630091 | Russia |
| Investigator Site 059 | Omsk | Russia |
| Investigator Site 062 | Orenburg | 460000 | Russia |
| Investigator Site 057 | Petrozavodsk | 185019 | Russia |
| Investigator Site 056 | Saint Petersburg | 192242 | Russia |
| Investigator Site 061 | Smolensk | 214025 | Russia |
| Investigator Site 060 | Vladimir | 600023 | Russia |
| Investigator Site 055 | Yekaterinburg | 620102 | Russia |
| Investigator Site 101 | Singapore | 119228 | Singapore |
| Investigator Site 355 | Daegu | South Korea |
| Investigator Site 352 | Daejeon | 301-721 | South Korea |
| Investigator Site 353 | Gwangju | 501-757 | South Korea |
| Investigator Site 351 | Jeollabuk-do | 561-712 | South Korea |
| Investigator Site 354 | Suwon | 443-721 | South Korea |
| Investigator Site 801 | Colombo | Sri Lanka |
| Investigator Site 804 | Kandy | Sri Lanka |
| Investigator Site 802 | Nugegoda | Sri Lanka |
| Investigator Site 452 | Kaohsiung City | 83301 | Taiwan |
| Investigator Site 455 | Taichung | 40447 | Taiwan |
| Investigator Site 454 | Taichung | Taiwan |
| Investigator Site 453 | Taipei | 100 | Taiwan |
| Investigator Site 451 | Taipei | 110 | Taiwan |
| Investigator Site 205 | Bangkok Noi | 10700 | Thailand |
| Investigator Site 202 | Khon Kaen | 40002 | Thailand |
| Investigator Site 204 | Muang Chiang Mai | 50200 | Thailand |
| Investigator Site 201 | Ratchathewi | 10400 | Thailand |
| Reset | Aug 13, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 10, 2018 | May 10, 2018 | |||
| Jul 17, 2018 | Aug 13, 2018 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C573858 | AMG623 peptibody |
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