JP2008501712A5 - - Google Patents

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JP2008501712A5
JP2008501712A5 JP2007515637A JP2007515637A JP2008501712A5 JP 2008501712 A5 JP2008501712 A5 JP 2008501712A5 JP 2007515637 A JP2007515637 A JP 2007515637A JP 2007515637 A JP2007515637 A JP 2007515637A JP 2008501712 A5 JP2008501712 A5 JP 2008501712A5
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antibody
medicament
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medicament according
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Priority claimed from PCT/US2005/019641 external-priority patent/WO2005117978A2/en
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Claims (38)

  1. 被験体における多発性硬化症を処置するための医薬であって、有効量のCD20抗体を被験体に投与して約0.5〜4グラムの最初の抗体暴露を与え、次いで約0.5〜4グラムの第2抗体暴露を与え、第2抗体暴露は最初の抗体暴露から約16〜60週まで与えられず、そして抗体暴露の各々は1または2用量の抗体として被験体に与えられることを特徴とする、医薬。
  2. 最初の抗体暴露から約20〜30週まで第二抗体暴露を与えない、請求項1に記載の医薬
  3. 最初の抗体暴露および第二抗体暴露を、各々約1.5〜2.5グラムの量で与える、請求項1または2に記載の医薬
  4. 医薬が、有効量のCD20抗体を被験体にさらに投与して約0.5〜4グラムの第3抗体暴露を与え、第3抗体暴露は最初の抗体暴露から約40〜60週まで行わないことを特徴とする、請求項2〜3のいずれか1つに記載の医薬
  5. 第三抗体暴露を、約1.5〜2.5グラムの量で与える、請求項4に記載の医薬
  6. 最初の抗体暴露から約46〜54週まで第三抗体暴露を与えない、請求項4または5に記載の医薬
  7. さらなる抗体曝露を、最初の抗体暴露から少なくとも約70〜75週まで与えない、請求項4〜6のいずれか1つに記載の医薬
  8. 最初の抗体暴露から約46〜60週まで第二抗体暴露を与えない、請求項1に記載の医薬
  9. 抗体暴露の各々を1用量の抗体として被験体に与える、請求項1〜8のいずれか1つに記載の医薬
  10. 抗体暴露の各々を2用量の抗体として被験体に与え、該2用量は第1用量と第2用量を構成する、請求項1〜8のいずれか1つに記載の医薬
  11. 第1用量が投与された時から約3〜17日に、第2用量を投与する、請求項10に記載の医薬
  12. 第1用量が投与された時から約6〜16日に、第2用量を投与する、請求項11に記載の医薬
  13. 第1用量が投与された時から約13〜16日に、第2用量を投与する、請求項12に記載の医薬
  14. 第1用量の抗体および第2用量の抗体が各々約0.5〜1.5グラムである、請求項10〜13のいずれか1つに記載の医薬
  15. 第1用量の抗体および第2用量の抗体が各々約0.75〜1.3グラムである、請求項10〜14のいずれか1つに記載の医薬
  16. 3回又は3回より多くの抗体暴露を被験体に対して行う、請求項1〜15のいずれか1つに記載の医薬
  17. 4回又は4回より多くの抗体暴露を被験体に対して行う、請求項1〜16のいずれか1つに記載の医薬
  18. 第2医薬を最初の抗体暴露又は後の抗体暴露と共に投与し、CD20抗体が第1医薬である、請求項1〜17のいずれか1つに記載の医薬
  19. 第2医薬が、インターフェロン、酢酸グラチラマー、細胞毒性作用物質、化学療法剤、ミトキサントロン、メトトレキセート、シクロホスファミド、クロラムブシル、アザチオプリン、γグロブリン、カムパス(Campath)、抗CD4、クラドリビン、コルチコステロイド、ミコフェノレートモフェチル(MMF)、シクロスポリン、スタチンクラスのコレステロール低下薬物、エストラジオール、テストステロン、ホルモン置換薬物、TNF阻害剤、疾患改変抗リウマチ薬物(DMARD)、非ステロイド抗炎症性薬物(NSAID)、レボチロキシン、シクロスポリンA、ソマトスタチン(somatastatin)アナログ、サイトカインまたはサイトカイン受容体アンタゴニスト、代謝拮抗物質、免疫抑制剤、インテグリンアンタゴニストもしくは抗体、LFA−1抗体、エファリズマブ、α4インテグリン抗体、ナタリズマブおよび他のB細胞表面マーカー抗体からなる群より選ばれる、請求項18に記載の医薬
  20. 多発性硬化症が再発−寛解多発性硬化症(RRMS)である、請求項1〜19のいずれか1つに記載の医薬
  21. 多発性硬化症が一次進行性多発性硬化症(PPMS)である、請求項1〜19のいずれか1つに記載の医薬
  22. 被験体はCD20抗体により決して前もって処置されていない、請求項1〜21のいずれか1つに記載の医薬
  23. 抗体が裸の抗体である、請求項1〜22のいずれか1つに記載の医薬
  24. 抗体が他の分子とコンジュゲートしている、請求項1〜22のいずれか1つに記載の医薬
  25. 他の分子が細胞毒性作用物質である、請求項24に記載の医薬
  26. 抗体を静脈内に投与する、請求項1〜25のいずれか1つに記載の医薬
  27. 抗体を、各抗体暴露のために静脈内に投与する、請求項26に記載の医薬
  28. 抗体を皮下に投与する、請求項1〜25のいずれか1つに記載の医薬
  29. 抗体を鞘内に投与する、請求項1〜25のいずれか1つに記載の医薬
  30. CD20抗体が、多発性硬化症を処置するために被験体に投与される唯一の医薬である、請求項1〜29のいずれか1つに記載の医薬
  31. 抗体がリツキシマブである、請求項1〜30のいずれか1つに記載の医薬
  32. 抗体が、配列番号2および8における可変ドメイン配列を含むヒト化2H7である、請求項1〜30のいずれか1つに記載の医薬
  33. 抗体が、配列番号23および24における可変ドメイン配列を含むヒト化2H7である、請求項1〜30のいずれか1つに記載の医薬
  34. 被験体が、高められた抗ミエリン塩基性タンパク質(MBP)、抗ミエリンオリゴデンドロサイト糖タンパク質(MOG)、抗ガングリオシドおよび/または抗ニューロフィラメント抗体レベルを有する、請求項1〜33のいずれか1つに記載の医薬
  35. 高められたレベルのB細胞が、被験体の脳脊髄液(CSF)、多発性硬化症病変または血清中に存在する、請求項1〜34のいずれか1つに記載の医薬
  36. (a)CD20抗体を含む容器、および
    (b)被験体の多発性硬化症を処置するための指示を有するパッケージインサートであって、該指示は、約0.5〜4グラムの最初の抗体暴露を与え、次いで約0.5〜4グラムの第2抗体暴露を与えるのに有効な量の抗体を被験体に投与し、最初の抗体暴露から約16〜60週まで第2抗体暴露を行わず、そして抗体暴露の各々は1または2用量の抗体として被験体に与えられることを指示している、パッケージインサート、
    を含む製造物。
  37. 第2医薬を含む容器をさらに含み、CD20抗体が第1医薬であり、そして第2医薬により被験体を処置するためのパッケージインサートにおける指示をさらに含む、請求項36に記載の製造物。
  38. 第2医薬が、インターフェロン、酢酸グラチラマー、細胞毒性作用物質、化学療法剤、ミトキサントロン、メトトレキセート、シクロホスファミド、クロラムブシル、アザチオプリン、γグロブリン、カムパス(Campath)、抗CD4、クラドリビン、コルチコステロイド、ミコフェノレートモフェチル(MMF)、シクロスポリン、スタチンクラスのコレステロール低下薬物、エストラジオール、テストステロン、ホルモン置換薬物、TNF阻害剤、疾患改変抗リウマチ薬物(DMARD)、非ステロイド抗炎症性薬物(NSAID)、レボチロキシン、シクロスポリンA、ソマトスタチン(somatastatin)アナログ、サイトカインまたはサイトカイン受容体アンタゴニスト、代謝拮抗物質、免疫抑制剤、および他のB細胞表面マーカー抗体からなる群より選ばれる、請求項37に記載の製造物。
JP2007515637A 2004-06-04 2005-06-02 多発性硬化症を処置するための方法 Pending JP2008501712A (ja)

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Application Number Priority Date Filing Date Title
US57699304P 2004-06-04 2004-06-04
PCT/US2005/019641 WO2005117978A2 (en) 2004-06-04 2005-06-02 Method for treating multiple sclerosis

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JP2008501712A JP2008501712A (ja) 2008-01-24
JP2008501712A5 true JP2008501712A5 (ja) 2008-07-17

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US (3) US20060051345A1 (ja)
EP (2) EP1753455A2 (ja)
JP (1) JP2008501712A (ja)
KR (3) KR20150092374A (ja)
CN (3) CN102512675A (ja)
AR (1) AR049200A1 (ja)
AU (1) AU2005249566B2 (ja)
BR (1) BRPI0510915A (ja)
CA (1) CA2566979A1 (ja)
IL (2) IL179139A (ja)
MX (1) MXPA06014069A (ja)
MY (1) MY194883A (ja)
NO (1) NO20070052L (ja)
NZ (1) NZ604082A (ja)
RU (1) RU2384345C2 (ja)
SG (1) SG183012A1 (ja)
SV (1) SV2006002132A (ja)
TW (2) TWI433682B (ja)
WO (1) WO2005117978A2 (ja)
ZA (1) ZA200610158B (ja)

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