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갑상샘 안구 질환 환자에서 Satralizumab의 효능, 안전성, 약동학 및 약력학을 평가하기 위한 연구 (SatraGO-1)

2026년 7월 7일 업데이트: Hoffmann-La Roche

중등도에서 중증 갑상선 안구 질환이 있는 참가자를 대상으로 Satralizumab의 효능, 안전성, 약동학 및 약력학을 평가하기 위한 3상, 무작위, 이중 마스킹, 위약 대조, 다기관 연구

이 연구의 목적은 갑상선 안구 질환(TED) 참가자를 대상으로 재조합 인간화 항인터루킨-6(IL-6) 수용체 단클론 항체인 피하 satralizumab의 효능, 안전성, 약동학 및 약력학을 평가하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

131

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일, 13353
        • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
      • Dresden, 독일, 01307
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
      • Essen, 독일, 45147
        • Universitatsklinikum Essen
      • Freiburg im Breisgau, 독일, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Münster, 독일, 48149
        • Universitatsklinikum Munster
      • Tübingen, 독일, 72076
        • Universitäts-Augenklinik Tübingen
  • 미국
    • California
      • Beverly Hills, California, 미국, 90210
        • Thrive Health Research LLC
      • La Jolla, California, 미국, 92093-0946
        • UCSD Shiley Eye Center
    • Kansas
      • Wichita, Kansas, 미국, 67206
        • Grene Vision Group, LLC
    • Maryland
      • Baltimore, Maryland, 미국, 21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, 미국, 48105
        • University of Michigan, Kellogg Eye Center
      • Saint Joseph, Michigan, 미국, 49085
        • Great Lakes Eye Care
    • New York
      • Great Neck, New York, 미국, 11021
        • 'Northwell Health Physician Partners Ophthalmology
    • Oregon
      • Portland, Oregon, 미국, 97225
        • EyeHealth Northwest
    • Texas
      • Austin, Texas, 미국, 78705-1169
        • Austin Retina Associates
    • Utah
      • Salt Lake City, Utah, 미국, 84102
        • Eyelid Center of Utah
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • WVU Eye Institute
  • 싱가포르
      • Singapore, 싱가포르, 119074
        • National University Hospital
      • Singapore, 싱가포르, 168751
        • Singapore Eye Research Institute
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1425
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Capital Federal, 아르헨티나, C1015ABO
        • Centro Oftalmologico Dr. Charles S.A.
      • Capital Federal, 아르헨티나, C1120AAN
        • Oftalmos
      • Ciudad Autonoma Buenos Aires, 아르헨티나, C1061AAE
        • Buenos Aires Mácula
      • Mendoza, 아르헨티나, M5500BWG
        • Centrovision Mendoza
      • Rosario, 아르헨티나, S2000DLA
        • Grupo Laser Vision
  • 오스트리아
      • Vienna, 오스트리아, 1090
        • Medizinische Universität Wien
  • 이탈리아
    • Campania
      • Naples, Campania, 이탈리아, 80131
        • A.O. U. Federico II
    • Lazio
      • Rome, Lazio, 이탈리아, 00168
        • Fondazione Policlinico Universitario A Gemelli
    • Lombardy
      • Milan, Lombardy, 이탈리아
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Varese, Lombardy, 이탈리아, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • Tuscany
      • Pisa, Tuscany, 이탈리아, 56124
        • Azienda Ospedaliero Universitaria Pisana
  • 일본
      • Aichi, 일본, 480-1195
        • Aichi Medical University Hospital
      • Fukuoka, 일본, 812-8582
        • Kyushu University Hospital
      • Fukuoka, 일본, 830-8577
        • Social Medical Corporation Tenjinkai Shinkoga Hospital
      • Hokkaido, 일본, 060-8648
        • Hokkaido University Hospital
      • Hyōgo, 일본, 657-0068
        • Kobe Kaisei Hospital Medical foundation
      • Kitakyushu-shi, 일본, 807-8556
        • Hospital of the University of Occupational and Environmental Health,Japan
      • Kyoto, 일본, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Miyazaki, 일본, 889-1692
        • University of Miyazaki Hospital
      • Osaka, 일본, 545-8586
        • Osaka Metropolitan university Hospital
      • Tokyo, 일본, 150-0001
        • Olympia Eye Hospital
  • 헝가리
      • Budapest, 헝가리, 1133
        • Budapest Retina Associates Kft.
  • 호주
    • New South Wales
      • Sydney, New South Wales, 호주, 2000
        • Sydney Eye Hospital
    • South Australia
      • Adelaide, South Australia, 호주, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, 호주, 3002
        • Centre For Eye Research Australia
  • 홍콩
      • Mong Kok, 홍콩
        • Hong Kong Eye Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

- CAS 기반의 갑상선 안질환(TED) 임상진단

제외 기준:

  • 스크리닝과 연구 기준선(제1일) 사이 연구 안구에서 각각 >= 2 포인트 또는 >= 2 mm의 CAS 또는 안구돌출 감소
  • 연구자의 판단에 따라 연구 과정 동안 즉각적인 외과적 안과 개입이 필요하거나 교정 수술 또는 방사선 조사를 계획하는 경우
  • 연구자의 판단에 따라 연구 참여를 배제하거나 연구 결과의 해석을 복잡하게 만드는 확인된 기존 안과 질환(의료 관리에 반응하지 않는 각막 대상부전 포함) 및 연구 동안 금지된 치료가 필요할 가능성이 있는 안과 질환 포함
  • 연구자의 판단에 따라 연구에 대한 개인의 안전한 참여 및 완료를 방해하는 임상 실험실 테스트의 모든 심각한 의학적 상태 또는 이상
  • 임신 또는 모유 수유 중이거나 연구 기간 동안 또는 사트랄리주맙의 최종 투여 후 12주 이내에 임신하려는 의도

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 사트랄리주맙
파트 I 기간에 참가자는 4주마다(q4w) 사트랄리주맙을 받고 연구 파트 II에서 안구돌출 반응 기반 개별 치료를 받게 됩니다.
의약품: 사트랄리주맙
Satralizumab은 SC 주사로 투여됩니다.
위약 비교기: 위약
1부 기간에 참가자는 4주차 위약을 받은 후 연구 2부에서 안구돌출증 반응 기반의 개별화된 치료를 받게 됩니다.
의약품: 위약
위약은 SC 주사로 투여됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: At Week 24
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 has been reported. Percentages have been rounded off.
At Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
기간: At Week 24
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 has been reported. Percentages have been rounded off.
At Week 24
Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
기간: At Week 24
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
기간: At Week 24
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
기간: At Week 24
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.
At Week 24
Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
기간: At Week 24
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.
At Week 24
Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24
기간: At Week 24
Percentages have been rounded off.
At Week 24
Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24
기간: At Week 24
Percentages have been rounded off.
At Week 24
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
기간: 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.
At Week 24
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
기간: 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.
At Week 24
Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
기간: At Week 24
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.
At Week 24
Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24
기간: At Week 24
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.
At Week 24
Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24
기간: At Week 24
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.
At Week 24
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
기간: 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. Percentages have been rounded off.
At Week 24
Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population
기간: 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.
At Week 24
Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
기간: At Week 24
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.
At Week 24
Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
기간: At Week 24
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).
At Week 24
Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye
기간: At Week 48
Percentage of participants 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.
At Week 48
Percentage of Participants Achieving Overall Response at Week 48
기간: 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
Percentage of Participants Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline at Week 48
기간: 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
Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
기간: At Week 48
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).
At Week 48
Percentage of Participants With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL at Week 48
기간: At 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.
At Week 48
Change From Baseline in Proptosis at Week 48
기간: At Week 48
At Week 48
Percentage of Participants Requiring Surgical Intervention for TED up to Week 48
기간: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
기간: From Week 24 to Week 48
From Week 24 to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
기간: From Baseline to Week 48
From Baseline to Week 48
Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48
기간: Week 24, Week 48
Week 24, Week 48
Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48
기간: Week 24, 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.
Week 24, Week 48
Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48
기간: At Week 48
At Week 48
Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48
기간: 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
Change in Proptosis From Week 24 to 48
기간: From Week 24 to Week 48
From Week 24 to Week 48
Change in CAS From Week 24 to 48
기간: 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 With a ≥6-point Improvement in the Visual Functioning and Appearance Subscale Score of the GO-QoL From Week 24 at Week 48
기간: Week 24, 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.
Week 24, Week 48
Change From Baseline in Proptosis to Week 48
기간: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in CAS to Week 48
기간: Baseline up 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 up to Week 48
Number of Participants With Adverse Events (AEs)
기간: Up to Week 72
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.
Up to Week 72
Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints
기간: Baseline, Weeks 2, 4, 8, 12 and 24
Baseline, Weeks 2, 4, 8, 12 and 24
Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study
기간: Up to Week 48
Up to Week 48

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

수사관

  • 연구 책임자: Clinical Trials, Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 10월 26일

기본 완료 (실제)

2025년 7월 8일

연구 완료 (실제)

2026년 6월 25일

연구 등록 날짜

최초 제출

2023년 7월 5일

QC 기준을 충족하는 최초 제출

2023년 8월 4일

처음 게시됨 (실제)

2023년 8월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GP44467
  • 2023-503309-13-00 (씨티스: EU CT Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

자격을 갖춘 연구원은 요청 플랫폼(www.vivli.org)을 통해 개별 환자 수준 데이터에 대한 액세스를 요청할 수 있습니다. 적격 연구에 대한 Roche의 기준에 대한 자세한 내용은 여기(https://vivli.org/ourmember/roche/)에서 확인할 수 있습니다.

임상 정보 공유에 관한 Roche의 글로벌 정책 및 관련 임상 연구 문서에 대한 액세스 요청 방법에 대한 자세한 내용은 여기(https://www.roche.com/innovation/process/clinical-trials/data-sharing/)를 참조하십시오. .

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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