甲状腺眼疾患の参加者におけるサトラリズマブの有効性、安全性、薬物動態および薬力学を評価する研究 (SatraGO-2) (SatraGO-2)
2026年7月20日 更新者：Hoffmann-La Roche
中等度から重度の甲状腺眼疾患の参加者におけるサトラリズマブの有効性、安全性、薬物動態、および薬力学を評価するための第III相、無作為化、二重マスク、プラセボ対照、多施設共同研究
この研究の目的は、甲状腺眼疾患 (TED) の参加者を対象に、組換えヒト化抗インターロイキン 6 (IL-6) 受容体モノクローナル抗体であるサトラリズマブの皮下投与の有効性、安全性、薬物動態、および薬力学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)
127
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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California
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San Diego、California、アメリカ、92108
- Plastics-Orbit-Neuro
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Connecticut
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Danbury、Connecticut、アメリカ、06810
- Connecticut Eye Consultants, P.C.
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Illinois
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Chicago、Illinois、アメリカ、60612
- University of Illinois Eye and Ear Infirmary
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Scheie Eye Institute
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Tennessee
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Nashville、Tennessee、アメリカ、37232-8808
- Vanderbilt Eye Institute
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Texas
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San Antonio、Texas、アメリカ、78251
- Retina Consultants of Texas
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Brighton、イギリス、BN2 5BF
- Sussex Eye Hospital
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Bristol、イギリス、BS1 2LX
- Bristol Eye Hospital
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Glasgow、イギリス、G12 0YN
- Gartnavel General Hospital
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Leeds、イギリス、LS9 7TF
- St James University Hospital
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Liverpool、イギリス、L7 8XP
- Royal Liverpool University Hospital
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London、イギリス、EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Maidstone, Kent、イギリス、ME16 9QQ
- Maidstone Hospital
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Jerusalem、イスラエル、9112001
- Hadassah MC
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Petah Tikva、イスラエル、4941492
- Rabin MC
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Ramat Gan、イスラエル
- Sheba medical center
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Alberta
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Edmonton、Alberta、カナダ
- University of Alberta
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Ontario
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Toronto、Ontario、カナダ、M3C 0G9
- Toronto Retina Institute
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Quebec
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Montreal、Quebec、カナダ、H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont
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Barcelona、スペイン、08035
- Hospital Universitario Vall D hebron
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Granada、スペイン、18012
- Hospital Universitario Virgen de las Nieves
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Madrid、スペイン、28040
- Hospital Universitario Clinico San Carlos
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Madrid、スペイン、28031
- Hospital Ramon y Cajal
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Seville、スペイン、41007
- Hospital Universitario Virgen De La Macarena
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Valencia、スペイン、46026
- Hospital Universitario la Fe: Servicio de Oftalmologia
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、スペイン、8907
- Hospital Universitari de Bellvitge
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Nantes、フランス、44093
- CHU Nantes - Hôtel Dieu
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Paris、フランス、75019
- Fondation Rothschild
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Paris、フランス、75012
- CHNO Hopital des Quinze Vingts
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Coimbra、ポルトガル、3000-548
- AIBILI - Association for Innovation and Biomedical Research on Light
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Bydgoszcz、ポーランド、85-316
- Specjalistyczny Osrodek Okulistyczny Oculomedica
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Gdansk、ポーランド、80-180
- Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
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Beijing、中国、100191
- Peking University Third Hospital
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Beijing、中国、100032
- Peking Union Medical College Hospital
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Beijing、中国、100730
- Beijing Hospital of Ministry of Health
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Beijing、中国、100730
- Beijing Tongren Hospital, Capital Medical University
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Xi'an、中国、710004
- Xi'an Fourth Hospital
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Seongnam-si、韓国、13620
- Seoul National University Bundang Hospital
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Seoul、韓国、003-722
- Severance Hospital, Yonsei University Health System
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Seoul、韓国、135-710
- Samsung Medical Center
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Seoul、韓国、06973
- Chung-Ang University Hospital
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- CASに基づく甲状腺眼疾患(TED)の臨床診断
除外基準:
- スクリーニングと研究ベースライン（1日目）の間の研究眼におけるCASまたは眼球突出のそれぞれ2ポイント以上または2 mm以上の減少
- 研究者の判断により、直ちに眼科的外科的介入が必要な場合、または研究期間中に矯正手術や放射線照射を計画している場合
- -研究者の判断により、医学的管理に反応しない角膜代償不全や、研究中に禁止された治療が必要となる可能性が高い眼科疾患など、研究参加を妨げたり、研究結果の解釈を複雑にしたりする既存の眼科疾患が特定された
- 研究者の判断により、個人の安全な研究への参加と完了を妨げる重篤な病状または臨床検査の異常
- -妊娠中または授乳中、または研究期間中またはサトラリズマブの最終投与後12週間以内に妊娠する予定がある
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：並列代入
- マスキング：4倍
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：サトラリズマブ
パート I の期間では、参加者は 4 週間ごと (q4w) にサトラリズマブの投与を受け、続いて研究のパート II で眼球突出反応に基づいた個別治療を受けます。
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サトラリズマブは皮下注射によって投与されます。
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プラセボコンパレーター：プラセボ
パート I の期間では、参加者はプラセボを q4w で受け、その後、研究のパート II で眼球突出反応に基づく個別治療を受けます。
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プラセボはSC注射によって投与されます
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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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Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
時間枠：At Week 24
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Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye have been reported.
Percentages have been rounded off.
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At Week 24
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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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Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
時間枠：At Week 24
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Participants with active TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
時間枠：At Week 24
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Participants with active and chronic inactive TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24
時間枠：At Week 24
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Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
時間枠：At Week 24
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Overall Response was defined as a ≥ 2-point reduction in clinical activity score (CAS), and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis (≥ 2-point/mm increase) in the fellow eye.
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24
時間枠：At Week 24
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CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24
時間枠：At Week 24
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CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Number of Participants With Adverse Events (AEs)
時間枠：Up to Week 72
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An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
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Up to Week 72
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Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints
時間枠：Baseline, Weeks 2, 4, 8, 12 and 24
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Baseline, Weeks 2, 4, 8, 12 and 24
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Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
時間枠：At Week 24
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Percentage of participants in the overall population (i.e., participants with active and chronic inactive TED) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye have been reported.
Percentages have been rounded off.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
時間枠：At Week 24
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This analysis used a Mixed-effects Model for Repeated Measure (MMRM) model.
Adjusted mean values have been reported here.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
時間枠：At Week 24
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This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Spontaneous Pain at Week 24
時間枠：At Week 24
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Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Visual Functioning Subscale of the Graves' Ophthalmopathy Quality-of-life (GO-QoL) From Baseline at Week 24
時間枠：At Week 24
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales, and is used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24
時間枠：At Week 24
|
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants With a ≥ 10-point Improvement in the Ocular Surface Disease Index (OSDI) Overall Scores Across All Levels of Baseline Severity at Week 24 in Overall Population
時間枠：At Week 24
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The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors.
It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100.
Higher scores represent a worse disease index.
Percentages have been rounded off.
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At Week 24
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Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population
時間枠：At Week 24
|
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors.
It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100.
Higher scores represent a worse disease index.
This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
時間枠：At Week 24
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Corneal staining was graded using Oxford Corneal Staining Chart which consists of a 6-point scale.
Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (0=absent; I=minimal; II=mild; III=moderate; IV= marked; and V=severe).
Higher grade indicates worse disease index.
The observer compares the overall appearance of the participant's corneal staining with the reference figure in the protocol.
The observer selects the appropriate grade that best represents the state of corneal staining.
The staining score were recorded for the exposed interpalpebral cornea and conjunctiva.
This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
時間枠：At Week 24
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The percentage of participants achieving a complete binocular diplopia response (diplopia score=0) at Week 24 have been reported.
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Percentages have been rounded off.
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At Week 24
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving ≥ 2 mm Reduction in Proptosis at Week 48 in the Study Eye
時間枠：At Week 48
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Percentage of participants (proptosis non-responders) who will achieve a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 48 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye will be reported.
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At Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving Overall Response at Week 48
時間枠：At Week 48
|
Overall Response is defined as a ≥ 2-point reduction in CAS, and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis ( ≥ 2-point/mm increase) in the fellow eye.
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
|
At Week 48
|
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 48
時間枠：Baseline to Week 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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Baseline to Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
時間枠：At Week 48
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
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At Week 48
|
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Percentage of Participants (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
時間枠：From Week 24 to Week 48
|
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
|
From Week 24 to Week 48
|
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Percentage of Participants (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
時間枠：From baseline up to Week 48
|
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
|
From baseline up to Week 48
|
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Change From Baseline in Proptosis at Week 48 (in Proptosis Non-responders at Week 24)
時間枠：Baseline and Week 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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Baseline and Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
時間枠：Up to Week 48
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Up to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
時間枠：From Week 24 to Week 48
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
時間枠：Baseline to Week 48
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Baseline to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Week 24 at Week 48
時間枠：Weeks 24 and 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Week 24 at Week 48
時間枠：Weeks 24 and 48
|
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Baseline at Week 48
時間枠：At Week 48
|
Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
|
At Week 48
|
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Baseline at Week 48
時間枠：At Week 48
|
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
|
At Week 48
|
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Change in Proptosis From Week 24 to 48 (in Proptosis Responders at Week 24)
時間枠：From Week 24 to Week 48
|
Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
|
From Week 24 to Week 48
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Change in CAS From Week 24 to 48 (in Proptosis Responders at Week 24)
時間枠：From Week 24 to Week 48
|
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
|
From Week 24 to Week 48
|
|
Percentage of Participants (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
時間枠：From Week 24 to Week 48
|
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
|
From Week 24 to Week 48
|
|
Percentage of Participants (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
時間枠：From baseline up to Week 48
|
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
|
From baseline up to Week 48
|
|
Change From Baseline in Proptosis to Week 48 (in Proptosis Responders at Week 24)
時間枠：Baseline to Week 48
|
Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
|
Baseline to Week 48
|
|
Change From Baseline in CAS to Week 48 (in Proptosis Responders at Week 24)
時間枠：Baseline to Week 48
|
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
|
Baseline to Week 48
|
|
Percentage of Participants (Proptosis Responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
時間枠：Up to Week 48
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Up to Week 48
|
|
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Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
時間枠：Up to Week 48
|
Participants will be considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).
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Up to Week 48
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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
捜査官
- スタディディレクター：Clinical Trials、Hoffmann-La Roche
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。
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 (実際)
2023年11月15日
一次修了 (実際)
2025年7月24日
研究の完了 (実際)
2026年6月25日
試験登録日
最初に提出
2023年10月25日
QC基準を満たした最初の提出物
2023年10月25日
最初の投稿 (実際)
2023年10月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月12日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GP44729
- 2023-503669-50-00 (Ctis：EU CT Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
資格のある研究者は、リクエスト プラットフォーム (www.vivli.org) を通じて個々の患者レベルのデータへのアクセスをリクエストできます。 適格な研究に関するロシュの基準の詳細は、こちら (https://vivli.org/ourmember/roche/) でご覧いただけます。
臨床情報の共有に関するロシュのグローバル ポリシーおよび関連する臨床研究文書へのアクセスをリクエストする方法の詳細については、こちら (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) を参照してください。 。
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
はい
米国FDA規制機器製品の研究
いいえ
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