- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02794285
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)
A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Mendoza, Argentina, 5500
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Quilmes, Argentina, 1878
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San Miguel de Tucuman, Argentina, T4000AXL
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Fitzroy, Australia, 3065
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Kogarah, Australia, 2217
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Plovdiv, Bulgaria, 4003
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Plovdiv, Bulgaria, 4002
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
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Quebec
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Rimouski, Quebec, Canada, G5L 5T1
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Osorno, Chile, 5311092
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Santiago, Chile, 8320000
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Vina del Mar, Chile, 2520997
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Armenia, Colombia, 630004
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Barranquilla, Colombia, 080002
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Medellín, Colombia, 050021
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Bordeaux, France, 33076
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Lille, France, 59037
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Montpellier CEDEX 5, France, 34295
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Paris Cedex 13, France, 75651
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Paris cedex 14, France, 75014
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Pessac, France, 33604
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Berlin, Germany, 10117
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Frankfurt am Main, Germany, 60528
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Hamburg, Germany, 20246
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Jena, Germany, 07747
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Kirchheim, Germany, 73230
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Mainz Am Rhein, Germany, 55131
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4032
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Szeged, Hungary, 6725
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Zalaegerszeg, Hungary, 8900
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Haifa, Israel, 31096
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Haifa, Israel, 31048
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 49281
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Tel Aviv, Israel, 64239
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Chiba-shi, Japan, 260-8712
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Chuo-ku, Japan, 104-8560
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Fukuoka-shi, Japan, 810-8539
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Fukuoka-shi, Japan, 810-0065
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Hiroshima-shi, Japan, 730-8619
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Kitakyushu-shi, Japan, 807-8556
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Kurashiki-shi, Japan, 710-8522
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Meguro-ku, Japan, 152-8902
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Meguro-ku, Japan, 153-8515
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Nagasaki-shi, Japan, 852-8501
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Omura-shi, Japan, 856-8562
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Sapporo-shi, Japan, 060-8648
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Sasebo-shi, Japan, 857-1195
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Sendai-shi, Japan, 980-8574
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Shinjuku-ku, Japan, 160-8582
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Daejeon, Korea, Republic of, 35015
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Gwangju, Korea, Republic of, 61469
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Jeju-si, Korea, Republic of, 690-767
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Seoul, Korea, Republic of, 06591
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Seoul, Korea, Republic of, 05030
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Seoul, Korea, Republic of, 07345
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Suwon-si, Korea, Republic of, 16499
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, LT-92288
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Chihuahua, Mexico, 31000
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Leon, Mexico, 37000
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Mexico, Mexico, 06700
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Mexico D.F., Mexico, 014080
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Mérida, Mexico, 97000
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San Luis Potosí, Mexico, 78213
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Arequipa, Peru, 04000
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Lima, Peru, 15033
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Lima, Peru, 15023
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Lima, Peru, 15046
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Lima, Peru, 15073
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Lima, Peru, 15102
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Bialystok, Poland, 15-297
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Bydgoszcz, Poland, 85 168
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Koscian, Poland, 64-000
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Kraków, Poland, 31-011
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Lublin, Poland, 20-607
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Nadarzyn, Poland, 05-830
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Starachowice, Poland, 27-200
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Szczecin, Poland, 71-252
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Ustron, Poland, 43-450
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Warszawa, Poland, 02-118
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Brasov, Romania, 500283
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Bucuresti, Romania, 011172
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Cluj Napoca, Romania, 400006
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Galati, Romania, 800578
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Targu Mures, Romania, 540136
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Smolensk, Russian Federation, 214015
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Tolyatti, Russian Federation, 445039
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Vladimir, Russian Federation, 600023
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Yaroslavl, Russian Federation, 150003
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Cape Town, South Africa, 7500
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Johannesburg, South Africa, 2021
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Stellenbosch, South Africa, 7600
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Barcelona, Spain, 08035
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Getafe, Spain, 28905
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Mérida, Spain, 06800
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Servilla, Spain, 41014
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Vigo, Spain, 36200
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Kaohsiung, Taiwan, 83301
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 10002
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Kyiv, Ukraine, 01601
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Kyiv, Ukraine, 03680
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Lviv, Ukraine, 79011
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Ternopil, Ukraine, 46001
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Uzhhorod, Ukraine, 88018
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Vinnytsia, Ukraine, 21018
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Zaporizhzhia, Ukraine, 69600
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Doncaster, United Kingdom, DN2 5LT
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Leeds, United Kingdom, LS7 4SA
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London, United Kingdom, SE1 9RT
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Manchester, United Kingdom, M13 9WL
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Alabama
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Birmingham, Alabama, United States, 35294-3280
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California
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El Cajon, California, United States, 92020
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Hemet, California, United States, 92543
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La Jolla, California, United States, 92037
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90024
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San Leandro, California, United States, 94578
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Thousand Oaks, California, United States, 91360
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Upland, California, United States, 91786
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Colorado
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Aurora, Colorado, United States, 80045
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Denver, Colorado, United States, 80230
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Florida
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Brandon, Florida, United States, 33511
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DeBary, Florida, United States, 32713
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33180
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Ormond Beach, Florida, United States, 32174
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Tampa, Florida, United States, 33614
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Vero Beach, Florida, United States, 32960
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Georgia
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Atlanta, Georgia, United States, 30322
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Decatur, Georgia, United States, 30033
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Lawrenceville, Georgia, United States, 30046
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Marietta, Georgia, United States, 30060
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Idaho
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Boise, Idaho, United States, 83702
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Idaho Falls, Idaho, United States, 83404
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Maryland
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Cumberland, Maryland, United States, 21502
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Hagerstown, Maryland, United States, 21740
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Michigan
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Grand Rapids, Michigan, United States, 49546
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Minnesota
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Minneapolis, Minnesota, United States, 55455-0341
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New Hampshire
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Nashua, New Hampshire, United States, 03060
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New Jersey
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Freehold, New Jersey, United States, 07728
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New Mexico
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Las Cruces, New Mexico, United States, 88011
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New York
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Brooklyn, New York, United States, 11201
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Great Neck, New York, United States, 11021
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New Hyde Park, New York, United States, 11042
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New York, New York, United States, 10016
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New York, New York, United States, 10021
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New York, New York, United States, 10032
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North Carolina
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Charlotte, North Carolina, United States, 28277
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Charlotte, North Carolina, United States, 28210
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Greenville, North Carolina, United States, 27834
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Raleigh, North Carolina, United States, 27617
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Ohio
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Middleburg Heights, Ohio, United States, 44130
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
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Oklahoma City, Oklahoma, United States, 73102
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15213
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Reading, Pennsylvania, United States, 19610
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South Carolina
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North Charleston, South Carolina, United States, 29406
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Tennessee
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Memphis, Tennessee, United States, 38119
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Memphis, Tennessee, United States, 38104
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Texas
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Amarillo, Texas, United States, 79124
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Austin, Texas, United States, 78745
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Austin, Texas, United States, 78726
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77034
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Houston, Texas, United States, 77004
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Mesquite, Texas, United States, 75150
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Stafford, Texas, United States, 77477
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Washington
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Spokane, Washington, United States, 99204
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Wisconsin
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Milwaukee, Wisconsin, United States, 53217
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
- Adequate peripheral venous access
- Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
Meets the following TB criteria:
- Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
- Newly positive QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must start on prophylaxis within 30 days of randomisation but prior to the second dose of investigational product (Visit 2/Week 4); OR
- Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005. The subject must have been diagnosed with latent TB and must have documentation confirming initiation of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
- Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
- In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
Exclusion Criteria:
Receipt of any of the following within the last 60 days:
- Azathioprine >200 mg/day
- Mycophenolate mofetil >2.0 g/day /mycophenolic acid >1.44 g/day
- Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
- Mizoribine >150 mg/day
- Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
Receipt of any of the following:
- Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)
- Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
- Active severe SLE-driven renal or neuropsychiatric disease
- Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
- Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
- Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
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Experimental: Anifrolumab
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Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)
Time Frame: Up to a maximum of 1114 days
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The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years. The following AESIs were pre-defined:
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Up to a maximum of 1114 days
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EAIRs of Serious Adverse Events (SAEs)
Time Frame: Up to a maximum of 1114 days
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EAIRs of SAEs are presented as event rate per 100 participant years. An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria:
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Up to a maximum of 1114 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Kalunian, MD, University of California, San Diego
- Study Director: Raj Tummala, MD, AstraZeneca
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3461C00009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AstraZenecaCompleted
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-
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