再発性多発性硬化症の参加者におけるウブリツキシマブの延長研究
再発性多発性硬化症患者におけるウブリツキシマブの非盲検延長試験
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
調査の概要
詳細な説明
TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 [NCT03277261]) or TG1101-RMS302 (RMS302 [NCT03277248]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E [NCT03381170]) (United States of America [USA] participants only).
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Pasadena、California、アメリカ、91105
- TG Therapeutics Investigational Trial Site
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Colorado
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Denver、Colorado、アメリカ、80045
- TG Therapeutics Investigational Trial Site
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Florida
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Miami、Florida、アメリカ、33136
- TG Therapeutics Investigational Trial Site
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Tampa、Florida、アメリカ、33612
- TG Therapeutics Investigational Trial Site
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Illinois
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Northbrook、Illinois、アメリカ、60062
- TG Therapeutics Investigational Trial Site
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Kansas
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Kansas City、Kansas、アメリカ、66160
- TG Therapeutics Investigational Trial Site
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Michigan
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Detroit、Michigan、アメリカ、48201
- TG Therapeutics Investigational Trial Site
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Nevada
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Las Vegas、Nevada、アメリカ、89106
- TG Therapeutics Investigational Trial Site
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New Jersey
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Teaneck、New Jersey、アメリカ、07666
- TG Therapeutics Investigational Trial Site
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131
- TG Therapeutics Investigational Trial Site
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New York
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Amherst、New York、アメリカ、14266
- TG Therapeutics Investigational Trial Site
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Ohio
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Columbus、Ohio、アメリカ、43214
- TG Therapeutics Investigational Trial Site
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Westerville、Ohio、アメリカ、43081
- TG Therapeutics Investigational Trial Site
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Tennessee
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Knoxville、Tennessee、アメリカ、37922
- TG Therapeutics Investigational Trial Site
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Texas
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Dallas、Texas、アメリカ、75246
- TG Therapeutics Investigational Trial Site
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Frisco、Texas、アメリカ、75034
- TG Therapeutics Investigational Trial Site
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Round Rock、Texas、アメリカ、78681
- TG Therapeutics Investigational Trial Site
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San Antonio、Texas、アメリカ、78258
- TG Therapeutics Investigational Trial Site
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Washington
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Seattle、Washington、アメリカ、98109
- TG Therapeutics Investigational Trial Site
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Cherkasy、ウクライナ、18009
- TG Therapeutics Investigational Trial Site
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Chernihiv、ウクライナ、14001
- TG Therapeutics Investigational Trial Site
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Chernihiv、ウクライナ、14029
- TG Therapeutics Investigational Trial Site
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Chernivtsi、ウクライナ、58002
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk、ウクライナ、76008
- TG Therapeutics Investigational Trial Site
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Kharkiv、ウクライナ、61058
- TG Therapeutics Investigational Trial Site
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Kharkiv、ウクライナ、61103
- TG Therapeutics Investigational Trial Site
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Kharkiv、ウクライナ、61176
- TG Therapeutics Investigational Trial Site
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Kyiv、ウクライナ、03037
- TG Therapeutics Investigational Trial Site
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Kyiv、ウクライナ、03115
- TG Therapeutics Investigational Trial Site
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Lviv、ウクライナ、79000
- TG Therapeutics Investigational Trial Site
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Lviv、ウクライナ、79010
- TG Therapeutics Investigational Trial Site
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Odesa、ウクライナ、65009
- TG Therapeutics Investigational Trial Site
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Poltava、ウクライナ、36011
- TG Therapeutics Investigational Trial Site
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Ternopil、ウクライナ、46027
- TG Therapeutics Investigational Trial Site
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Uzhhorod、ウクライナ、88018
- TG Therapeutics Investigational Trial Site
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Vinnytsia、ウクライナ、21005
- TG Therapeutics Investigational Trial Site
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Zaporizhia、ウクライナ、69065
- TG Therapeutics Investigational Trial Site
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Zaporizhia、ウクライナ、96900
- TG Therapeutics Investigational Trial Site
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Zhytomyr、ウクライナ、10002
- TG Therapeutics Investigational Trial Site
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Osijek、クロアチア、31000
- TG Therapeutics Investigational Trial Site
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Varaždin、クロアチア、42000
- TG Therapeutics Investigational Trial Site
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Zagreb、クロアチア、10000
- TG Investigational Trial Site
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Tbilisi、グルジア、00112
- TG Therapeutics Investigational Trial Site
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Tbilisi、グルジア、00114
- TG Therapeutics Investigational Trial Site
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Tbilisi、グルジア、00159
- TG Therapeutics Investigational Trial Site
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Tbilisi、グルジア、00160
- TG Therapeutics Investigational Trial Site
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Tbilisi、グルジア、00172
- TG Therapeutics Investigational Trial Site
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Tbilisi、グルジア、00179
- TG Therapeutics Investigational Trial Site
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Belgrade、セルビア、11000
- TG Therapeutics Investigational Trial Site
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Kragujevac、セルビア、34000
- TG Therapeutics Investigational Trial Site
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Grodno、ベラルーシ、230017
- TG Therapeutics Investigational Trial Site
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Grodno、ベラルーシ、320017
- TG Therapeutics Investigational Trial Site
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Minsk、ベラルーシ、220114
- TG Therapeutics Investigational Trial Site
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Minsk、ベラルーシ、220116
- TG Therapeutics Investigational Trial Site
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Minsk、ベラルーシ、220226
- TG Therapeutics Investigational Trial Site
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Katowice、ポーランド、40-555
- TG Therapeutics Investigational Trial Site
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Katowice、ポーランド、40-568
- TG Therapeutics Investigational Trial Site
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Katowice、ポーランド、40-684
- TG Therapeutics Investigational Trial Site
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Krakow、ポーランド、31-505
- TG Therapeutics Investigational Trial Site
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Lodz、ポーランド、41-800
- TG Therapeutics Investigational Trial Site
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Olsztyn、ポーランド、10-561
- TG Therapeutics Investigational Trial Site
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Poznan、ポーランド、61-583
- TG Therapeutics Investigational Trial Site
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Warsaw、ポーランド、04-141
- TG Therapeutics Investigational Trial Site
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Zabrze、ポーランド、04-749
- TG Therapeutics Investigational Trial Site
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Arkhangelsk、ロシア、163045
- TG Therapeutics Investigational Trial Site
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Barnaul、ロシア、656045
- TG Therapeutics Investigational Trial Site
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Bryansk、ロシア、241033
- TG Therapeutics Investigational Trial Site
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Chelyabinsk、ロシア、454021
- TG Therapeutics Investigational Trial Site
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Kemerovo、ロシア、650066
- TG Therapeutics Investigational Trial Site
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Krasnoyarsk、ロシア、660037
- TG Therapeutics Investigational Trial Site
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Kursk、ロシア、305007
- TG Therapeutics Investigational Trial Site
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Moscow、ロシア、125367
- TG Therapeutics Investigational Trial Site
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Moscow、ロシア、127015
- TG Therapeutics Investigational Trial Site
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Nizhny Novgorod、ロシア、603155
- TG Therapeutics Investigational Trial Site
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Novosibirsk、ロシア、630007
- TG Therapeutics Investigational Trial Site
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Novosibirsk、ロシア、630087
- TG Therapeutics Investigational Trial Site
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Pyatigorsk、ロシア、357538
- TG Therapeutics Investigational Trial Site
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Saint Petersburg、ロシア、197002
- TG Therapeutics Investigational Trial Site
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Saint Petersburg、ロシア、197110
- TG Therapeutics Investigational Trial Site
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Saint Petersburg、ロシア、197376
- TG Therapeutics Investigational Trial Site
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Saransk、ロシア、430032
- TG Therapeutics Investigational Trial Site
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Smolensk、ロシア、214018
- TG Therapeutics Investigational Trial Site
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Tomsk、ロシア、634050
- TG Therapeutics Investigational Trial Site
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Tyumen、ロシア、625000
- TG Therapeutics Investigational Trial Site
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Ufa、ロシア、450005
- TG Therapeutics Investigational Trial Site
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Yekaterinburg、ロシア、620102
- TG Therapeutics Investigational Trial Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Participants must meet the following criteria:
- Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
- Investigator believes may benefit from treatment with ublituximab
- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
Exclusion Criteria:
Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
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Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- Absolute neutrophil count < 1.5 x 10e3/µL
- Hematocrit < 24%
- Platelet count < 150,000 cell/mm^3
- Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L
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Active infection
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Ongoing pregnancy (female participants)
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Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
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Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
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Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
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Participants with unstable disease activity
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Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
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Vaccination with live virus within 2 months of randomization
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Ublituximab Infusions
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study. |
Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.
他の名前：
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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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Annualized Relapse Rate (ARR)
時間枠：Up to Week 336
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ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years). |
Up to Week 336
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- TG1101-RMS303
- 2019-003625-16 (EudraCT番号)
- 2019 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。