全身性エリテマトーデスの参加者におけるLY2127399の研究
2018年6月18日 更新者：Eli Lilly and Company
全身性エリテマトーデス (SLE) 患者における皮下 LY2127399 の有効性と安全性を評価する第 3 相、多施設、無作為化、二重盲検、プラセボ対照試験
この SLE 研究の目的は、活動性 SLE の参加者を対象に、標準治療に加えて LY2127399 の 2 つの異なる用量を投与した場合の有効性、安全性、忍容性を評価することです。
調査の概要
研究の種類
介入
入学 (実際)
1124
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Anniston、Alabama、アメリカ、36207
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Birmingham、Alabama、アメリカ、35216
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Arizona
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Gilbert、Arizona、アメリカ、85234
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Scottsdale、Arizona、アメリカ、85258
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Tempe、Arizona、アメリカ、85282
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkansas
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Malvern、Arkansas、アメリカ、72104
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California
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Covina、California、アメリカ、91723
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El Cajon、California、アメリカ、92020
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Escondido、California、アメリカ、92027
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La Mesa、California、アメリカ、91941
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Lakewood、California、アメリカ、90712
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Los Alamitos、California、アメリカ、90720
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Los Angeles、California、アメリカ、90095
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Pasadena、California、アメリカ、91107
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Riverside、California、アメリカ、92506
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San Diego、California、アメリカ、92108
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San Gabriel、California、アメリカ、91776
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santa Barbara、California、アメリカ、93108
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Van Nuys、California、アメリカ、91405
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Westlake Village、California、アメリカ、91361
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Whittier、California、アメリカ、90606
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Colorado
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Aurora、Colorado、アメリカ、80045
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District of Columbia
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Washington、District of Columbia、アメリカ、20060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Aventura、Florida、アメリカ、33180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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DeBary、Florida、アメリカ、32713
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miami、Florida、アメリカ、33175
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Naples、Florida、アメリカ、34102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Port Richey、Florida、アメリカ、34652
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ormond Beach、Florida、アメリカ、32174
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pensacola、Florida、アメリカ、32514
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pinellas Park、Florida、アメリカ、33781
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plantation、Florida、アメリカ、33324
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Miami、Florida、アメリカ、33143
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tampa、Florida、アメリカ、33603
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vero Beach、Florida、アメリカ、32960
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
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Atlanta、Georgia、アメリカ、30303
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Duluth、Georgia、アメリカ、30096
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lithonia、Georgia、アメリカ、30038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Meridian、Idaho、アメリカ、83642
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Chicago、Illinois、アメリカ、60612
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rockford、Illinois、アメリカ、61107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Fort Wayne、Indiana、アメリカ、46804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Granger、Indiana、アメリカ、46530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indianapolis、Indiana、アメリカ、46202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Louisiana
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Monroe、Louisiana、アメリカ、71203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maine
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Portland、Maine、アメリカ、04102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Cumberland、Maryland、アメリカ、21502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Saint Clair Shores、Michigan、アメリカ、48081
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Minnesota
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Duluth、Minnesota、アメリカ、55805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mississippi
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Hattiesburg、Mississippi、アメリカ、39402
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Saint Louis、Missouri、アメリカ、63117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas、Nevada、アメリカ、89128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Hampshire
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Nashua、New Hampshire、アメリカ、03060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Freehold、New Jersey、アメリカ、07728
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Voorhees、New Jersey、アメリカ、08043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Mexico
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Las Cruces、New Mexico、アメリカ、88011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Albany、New York、アメリカ、12206
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brooklyn、New York、アメリカ、11201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manhasset、New York、アメリカ、11030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York、New York、アメリカ、10021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York、New York、アメリカ、10016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plainview、New York、アメリカ、11803
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Roslyn、New York、アメリカ、11576
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charlotte、North Carolina、アメリカ、28204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Raleigh、North Carolina、アメリカ、27617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rocky Mount、North Carolina、アメリカ、27804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cleveland、Ohio、アメリカ、44109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toledo、Ohio、アメリカ、43606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Duncansville、Pennsylvania、アメリカ、16635
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wyomissing、Pennsylvania、アメリカ、19610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Cookeville、Tennessee、アメリカ、38501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Knoxville、Tennessee、アメリカ、37909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis、Tennessee、アメリカ、38163
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nashville、Tennessee、アメリカ、37203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Amarillo、Texas、アメリカ、79124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Austin、Texas、アメリカ、78745
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nassau Bay、Texas、アメリカ、77058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Round Rock、Texas、アメリカ、78665
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio、Texas、アメリカ、78232
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Victoria、Texas、アメリカ、77901
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Saint George、Utah、アメリカ、84790
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Seattle、Washington、アメリカ、98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Spokane、Washington、アメリカ、99204
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West Virginia
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Clarksburg、West Virginia、アメリカ、26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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London、イギリス、SE1 7EH
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Cambridgeshire
-
Cambridge、Cambridgeshire、イギリス、CB2 0QQ
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Dorset
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Poole、Dorset、イギリス、BH15 2JB
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Greater London
-
London、Greater London、イギリス、E11 1NR
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Kent
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Maidstone、Kent、イギリス、ME16 9QQ
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Lancashire
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Wigan、Lancashire、イギリス、WN6 0LW
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Haifa、イスラエル、34362
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Kfar Saba、イスラエル、44281
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Petah Tikva、イスラエル、49100
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Tel Hashomer、イスラエル、52651
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Zerifin、イスラエル、70300
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Bangalore、インド、560043
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Gujarat、インド、380015
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Haryana、インド、122001
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Hyderabaad、インド、500082
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Kormangala、インド、560034
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Pune、インド、411007
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Trivandrum、インド、695011
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Cuenca、エクアドル、EC010150
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Guayaquil、エクアドル、90110321
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-
Quito、エクアドル、17
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Malvern East、オーストラリア、3145
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New South Wales
-
St Leonards、New South Wales、オーストラリア、2065
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Queensland
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Cairns、Queensland、オーストラリア、4870
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Maroochydore、Queensland、オーストラリア、4558
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Victoria
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Clayton、Victoria、オーストラリア、3168
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Heidelberg、Victoria、オーストラリア、3081
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Ontario
-
Hamilton、Ontario、カナダ、L8N 3Z5
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Quebec
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Trois-Rivieres、Quebec、カナダ、G8Z 1Y2
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Barcelona、スペイン、08035
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-
Bilbao、スペイン、48013
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La Coruña、スペイン、15006
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Las Palmas De Gran Canaria、スペイン、35010
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-
Madrid、スペイン、28040
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-
Málaga、スペイン、29010
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-
Santiago De Compostela、スペイン、15706
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-
Sevilla、スペイン、41071
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-
Vigo、スペイン、36200
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Belgrade、セルビア、11000
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Kragujevac、セルビア、34000
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Niska Banja、セルビア、18205
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Novi Sad、セルビア、21000
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La Marsa、チュニジア、2070
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-
Monastir、チュニジア、5000
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-
Sfax、チュニジア、3029
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-
Sousse、チュニジア、4000
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-
Tunis、チュニジア、1008
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Tunis Monfleury、チュニジア、1008
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Hamilton、ニュージーランド、3204
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-
Otahuhu、ニュージーランド、1640
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-
Takapuna、ニュージーランド、622
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Budapest、ハンガリー、1027
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-
Debrecen、ハンガリー、4032
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Gyor、ハンガリー、9023
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-
Gyula、ハンガリー、5700
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Szeged、ハンガリー、6720
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Orleans、フランス、45000
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Strasbourg、フランス、67091
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Campinas、ブラジル、13015-011
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Goiania、ブラジル、74110-120
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Juiz De Fora、ブラジル、36010-570
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Porto Alegre、ブラジル、91350-200
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Salvador、ブラジル、40050-410
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São Paulo、ブラジル、04039-901
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Kota Kinabalu、マレーシア、88586
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Kuala Lumpur、マレーシア、59100
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Guadalajara、メキシコ、44650
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Merida、メキシコ、97130
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Mexico City、メキシコ、06090
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San Luis、メキシコ、78240
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San Luis Potosi、メキシコ、78200
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Tijuana、メキシコ、22010
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Riga、ラトビア、LV-1002
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Brasov、ルーマニア、500283
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Bucharest、ルーマニア、020475
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Cluj-Napoca、ルーマニア、400006
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Galati、ルーマニア、800587
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Iasi、ルーマニア、700656
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Targu Mures、ルーマニア、540136
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Chelyabinsk、ロシア連邦、454076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ekaterinburg、ロシア連邦、620012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kazan、ロシア連邦、420097
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kemerovo、ロシア連邦、650099
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow、ロシア連邦、125101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orenburg、ロシア連邦、460018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg、ロシア連邦、197089
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tomsk、ロシア連邦、634063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yaroslavl、ロシア連邦、150023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cape Town、南アフリカ、7925
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Durban、南アフリカ、4001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stellenbosch、南アフリカ、7600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changhua、台湾、500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hualien、台湾、970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung、台湾、833
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung、台湾、40705
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung City、台湾、40201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei、台湾、10630
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (アダルト、OLDER_ADULT)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
包含基準:
- American College of Rheumatology (ACR) 基準で定義された SLE の臨床診断
- 抗核抗体陽性（ANA）
- -試験の過程で妊娠しないことに同意する
- スクリーニングのSELENA-SLEDAIスコアが6以上であること。 (参加者は、スクリーニング当日にセレナ-スレダイのスクリーニングで採点されたすべての症状を積極的に示している必要があります。)
除外基準:
- -アクティブな重度のループス腎疾患がある
- アクティブな中枢神経系または末梢神経疾患がある
- -無作為化から180日以内に静脈内免疫グロブリン（IVIg）を受けた
- -スクリーニングから30日以内に活動中または最近の感染がある
- -無作為化から90日以内に深刻な感染症にかかった
- B型肝炎の証拠があるか、検査で陽性である
- C型肝炎にかかっている
- ヒト免疫不全ウイルス（HIV）陽性ですか
- 活動性または潜在性結核 (TB) の証拠がある
- -スクリーニング時の重大な検査異常の存在
- -過去5年間に悪性腫瘍があったが、無作為化前の3年間に再発することなく完全に切除された子宮頸部癌腫または基底細胞または扁平上皮皮膚細胞を除く
- 過去 30 日間に 40 mg 以上のプレドニゾンまたは同等品を摂取したことがある
- 過去 30 日間に抗マラリア薬の服用量を変更した
- 過去90日間に免疫抑制剤の服用量を変更した
- 以前にリツキシマブを受けたことがある
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：平行
- マスキング：四重
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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PLACEBO_COMPARATOR：プラセボ
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皮下注射で52週間投与。
最初の投与時に、対応する負荷量も投与されます。
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実験的：LY2127399 2週間ごと
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皮下注射で120mgを52週間投与。
240 mgの負荷用量が、治験薬の初回用量として投与されます
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実験的：LY2127399 4 週間ごと
治療期間中、盲目的に、参加者は LY2127399 の注射とプラセボの注射を 2 週間ごとに交互に行います。
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皮下注射で52週間投与。
皮下注射で120mgを52週間投与。
240 mgの負荷用量が、治験薬の初回用量として投与されます
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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52週目にSLEレスポンダー指数の反応を達成した参加者の割合
時間枠：52週
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ベースラインと比較して、SELENA SLEDAI スコアがベースラインから 5 ポイント以上減少し、PGA が悪化 (ベースラインから 0.30 ポイント未満の増加) せず、新しい BILAG A 臓器ドメイン スコアまたは 2 つの新しい BILAG B 臓器ドメイン スコアを示した参加者の割合. SELENA SLEDAI は、9 つの器官系にわたる 24 の個々の記述子から計算されます。 0 は非活動性疾患を示し、理論上の最大スコアは 105 です。スコア > 20 はまれです。 PGA は、0 から 3 までの視覚的アナログ スケールです (0 = なし、1 = 軽度、2 = 中等度、3 = 重度)。 BILAG は、9 つの臓器ドメインごとに 1 つのスコアを使用します。範囲は重度 (A) から無病 (E) までです。 許可された併用薬の要件を順守できなかった参加者は、脱落したか、52週目のデータが欠落していた参加者と同様に、非応答者と見なされました。 |
52週
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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抗二本鎖デオキシリボ核酸（抗dsDNA）レベルのベースラインから52週間への変化
時間枠：ベースライン、52週間
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抗二本鎖デオキシリボ核酸 (抗 dsDNA) は、SLE の診断を支援するために使用されるラボ分析物です。
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ベースライン、52週間
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全身性エリテマトーデス疾患活動指数（SLEDAI2K）スコアのベースラインから52週間のエンドポイントへの変化
時間枠：ベースライン、52週間
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SLE 疾患活動指数 2000 (SLEDAI-2K) スコアは、狼瘡疾患活動性の加重累積指数です。
SLEDAI-2K は、9 つの器官系にわたる 24 の個々の記述子から計算されます。 0 は非活動性疾患を示し、理論上の最大スコアは 105 です。
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ベースライン、52週間
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最初の重度の SLE フレア (SFI) までの時間
時間枠：52週までのベースライン
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SFI は、SELENA-SLEDAI 疾患活動性指数スコア、疾患活動性シナリオ、治療の変更、および PGA を使用して、軽度/中程度および重度のフレアを定義します。 この指数は、合計スコアの絶対変化、新たな症状または症状の悪化、および疾患活動性によるコルチコステロイドの使用または入院の増加を考慮に入れています。 最初の重度の SLE フレア (SFI) までの時間 (日数) は、(最初の重度の SLE フレアの開始日 (SFI) - 無作為化日 + 1) として計算されます。 |
52週までのベースライン
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簡単な疲労インベントリ (BFI) スコアのベースラインから 52 週間のエンドポイントへの変更
時間枠：ベースライン、52週間
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過去 24 時間に経験した最悪の疲労に基づいて疲労の重症度を測定する、参加者が報告した尺度。
重症度スコアは、0 (疲労なし) から 10 (想像できるほど深刻な疲労) の範囲でした。
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ベースライン、52週間
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最初の新しいイギリス諸島ループス評価グループ (BILAG A) または 2 つの新しい BILAG B SLE フレアまでの時間
時間枠：52週までのベースライン
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British Isles Lupus Assessment Group (BILAG) は、9 つの臓器系ドメインにわたる世界的な疾患活動を評価します。 BILAG フレアは、BILAG2004 インデックス フレア ルールを使用して、9 つの臓器ドメインのそれぞれについて評価されます。 Aは重度のフレア、Bは中等度のフレアです。 最初の BILAG A または 2 回の BILAG B フレアまでの時間 (日数) は、(最初の BILAG A または 2 回の BILAG B フレアの開始日 - 無作為化日 + 1) として計算されます。 2 つの BILAG B フレアは、同じ来院時に異なるドメインで発生する必要があります。 |
52週までのベースライン
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52週でコルチコステロイド用量が増加した参加者の割合
時間枠：52週
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訪問時のコルチコステロイドの増加は、前回の予定された訪問以降に摂取されたコルチコステロイドの平均 1 日用量を使用して、用量またはプレドニゾンまたは同等物が 2.5 mg/日を超えるベースラインからの変化として定義されました。
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52週
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SELENA-SLEDAI疾患活動性スコアのベースラインから52週間のエンドポイントへの変更
時間枠：ベースライン、52週間
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エリテマトーデス全国評価におけるエストロゲンの安全性 - SLE 疾患活動指数 (SELENA-SLEDAI) スコアは、ループス疾患活動の加重累積指数です。
SELENA-SLEDAI は、9 つの器官系にわたる 24 の個々の記述子から計算されます。 0 は非活動性疾患を示し、理論上の最大スコアは 105 です。
|
ベースライン、52週間
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52週目に疾患活動性を増加させずにプレドニゾンまたは同等の用量を減らすことができた参加者の割合
時間枠：52週
|
参加者は、24 週から 52 週の間に次の基準を満たした場合、コルチコステロイド節約効果 (静止疾患) を達成します。プレドニゾンまたは同等の用量を 7.5 mg/日以下に減らすことができ、疾患が静止しており (9 つのシステムすべてで BILAG C スコア以上)、過去 3 か月間に BILAG A または B の再燃がなく、どちらの値も増加していない訪問中または訪問前の抗マラリア薬または免疫抑制剤。
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52週
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Physician's Global Assessment (PGA) のベースラインから 52 週のエンドポイントへの変更
時間枠：ベースライン、52週間
|
PGA は、参加者の現在の疾患活動性レベルを単一項目の臨床医が評価した評価であり、連続的な 100 ミリメートル (mm) の視覚的分析スケールで測定され、ベンチマークは左から右に 0、1、2、および 3 で、なし、軽度に対応します。 、中程度、および重度の SLE 疾患の活動性。
スコアは 0 から 100 まで表示されます。
ベースラインから0.30ポイント以下の増加として定義される悪化なし。
|
ベースライン、52週間
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ベースラインから 52 週のエンドポイントへの変更 ループスの生活の質 (LupusQOL) ドメイン スコア
時間枠：ベースライン、52週間
|
LupusQoL は、8 つのドメイン内の SLE を持つ参加者の健康関連の生活の質 (HRQoL) を測定するように設計された、疾患固有の 34 項目の自己報告式アンケートです。回答は 0 (常に) から 4 (決して)。
各ドメインの LupusQoL スコアは 0 ～ 100 のスケールで報告され、値が大きいほど HRQoL が優れていることを示します。
|
ベースライン、52週間
|
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52週間で医師の総合評価（PGA）スコアが悪化していない参加者の割合
時間枠：52週
|
Physician's Global Assessment (PGA) は、参加者の現在の疾患活動性レベルを単一項目で臨床医が評価した評価であり、連続的な 100 mm 視覚分析スケールで測定され、左から右に 0、1、2、および 3 のベンチマークがあり、なしに対応します。 、軽度、中等度、および重度の SLE 疾患活動性。
スコアは 0 ～ 100 で表示されます。悪化なしとは、ベースラインから 0.30 ポイント以下の増加として定義されます。
|
52週
|
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ベースラインと比較して、新しい BILAG A 疾患活動性スコアがなく、新しい BILAG B 疾患活動性スコアが 1 つ以下の参加者の数
時間枠：52週までのベースライン
|
British Isles Lupus Assessment Group (BILAG) は、9 つの臓器系ドメインにわたる世界的な疾患活動を評価します。
BILAG フレアは、BILAG2004 インデックス フレア ルールを使用して、9 つの臓器ドメインのそれぞれについて評価されます。 Aは重度のフレア、Bは中等度のフレアです。
|
52週までのベースライン
|
|
52週でBILAG Aまたは1つ以下のBILAG B臓器ドメインのフレアを伴う修正SRIによって測定される応答を達成する参加者の割合
時間枠：52週
|
ベースラインと比較して、SELENA SLEDAI スコアがベースラインから 5 ポイント以上減少し、PGA が悪化 (ベースラインから 0.30 ポイント未満の増加) せず、新しい BILAG A または 1 つ以下の新しい BILAG B 器官ドメインのフレアが認められた参加者の割合. (BILAG 疾患スコアの代わりに BILAG フレアを使用するように変更された主要な結果) SELENA SLEDAI は、9 つの器官系にわたる 24 の個々の記述子から計算されます。 0 は非活動性疾患を示し、理論上の最大スコアは 105 です。 PGA は、0 から 3 までの視覚的アナログ スケールです (0 = なし、1 = 軽度、2 = 中等度、3 = 重度)。 BILAG フレアは、9 つの臓器ドメインごとに評価されます。 Aは重度のフレア、Bは中等度のフレアです。 許可された併用薬の要件を順守できなかった参加者は、脱落したか、52週目のデータが欠落していた参加者と同様に、非応答者と見なされました。 |
52週
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.
- Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.
- Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.
- Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.
- Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.
- Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年1月1日
一次修了 (実際)
2014年8月1日
研究の完了 (実際)
2015年3月1日
試験登録日
最初に提出
2010年9月17日
QC基準を満たした最初の提出物
2010年9月17日
最初の投稿 (見積もり)
2010年9月20日
学習記録の更新
投稿された最後の更新 (実際)
2018年7月17日
QC基準を満たした最後の更新が送信されました
2018年6月18日
最終確認日
2018年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 13653
- H9B-MC-BCDT (他の：Eli Lilly and Company)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。