An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab
An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab
(2)治験責任医師等に関する事項
佐藤 利之
Sato Toshiyuki
/
株式会社新日本科学PPD
PPDSNBL K.K
104-0044
/
東京都中央区明石町8番1号 聖路加タワー12階
St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan
03-6821-0900
Toshiyuki.Sato@ppd.com
佐藤 利之
Sato Toshiyuki
株式会社新日本科学PPD
PPDSNBL K.K
104-0044
東京都中央区明石町8番1号 聖路加タワー12階
St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan
03-6821-0900
Toshiyuki.Sato@ppd.com
令和2年11月2日
(3)その他の試験等に従事する者に関する事項
(4)多施設共同試験等における治験責任医師等に関する事項など
多施設共同試験等の該当の有無
あり
/
/
公益社団法人 京都保健会京都民医連中央病院
Kyoto Min-iren Chuo Hospital
京都府
/
/
青森県立中央病院
Aomori Prefectural Central Hospital
青森県
/
/
国立大学法人東北大学 東北大学病院
National University Corporation Tohoku University Tohoku University Hospital
Has any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of patient safety or study results
Lactating or pregnant females, or females who intend to become pregnant after signing the informed consent
年齢下限 / Age Minimum
18歳 以上
18age old over
年齢上限 / Age Maximum
上限なし
No limit
性別 / Gender
男性・女性
Both
中止基準
対象疾患名 / Health Condition(s) or Problem(s) Studied
視神経脊髄炎(NMO)及びNMO関連疾患
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects.
To provide continuation of inebilizumab treatment to patients who completed the OLP of Study CD-IA-MEDI-551-1155, and to characterize the effects of long term inebilizumab treatment on safety, laboratory, and other measures; and to monitor recovery of particular laboratory measures following discontinuation of inebilizumab.