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Tutkimus, jossa arvioidaan satralitsumabin tehoa, turvallisuutta, farmakokinetiikkaa ja farmakodynamiikkaa kilpirauhasen silmäsairautta sairastavilla potilailla (SatraGO-1)

tiistai 7. heinäkuuta 2026 päivittänyt: Hoffmann-La Roche

Vaiheen III, satunnaistettu, kaksoisnaamioinen, lumekontrolloitu, monikeskustutkimus satralitsumabin tehon, turvallisuuden, farmakokinetiikka ja farmakodynamiikka arvioimiseksi potilailla, joilla on kohtalainen tai vaikea kilpirauhasen silmäsairaus

Tämän tutkimuksen tarkoituksena on arvioida ihonalaisen satralitsumabin, rekombinantin, humanisoidun anti-interleukiini-6 (IL-6) -reseptorin monoklonaalisen vasta-aineen, tehoa, turvallisuutta, farmakokinetiikkaa ja farmakodynamiikkaa kilpirauhasen silmäsairautta (TED) sairastavilla potilailla.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

131

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

- Kilpirauhasen silmäsairauden (TED) kliininen diagnoosi CAS:n perusteella

Poissulkemiskriteerit:

  • CAS:n tai proptoosin väheneminen >= 2 pistettä tai >= 2 mm, vastaavasti, tutkimussilmässä seulonnan ja tutkimuksen lähtötilanteen välillä (päivä 1)
  • Vaatii välitöntä kirurgista oftalmologista toimenpidettä tai suunnittelee korjaavaa leikkausta tai säteilytystä tutkimuksen aikana, tutkijan harkinnan mukaan
  • Tunnistettu jo olemassa oleva silmäsairaus, joka tutkijan arvion mukaan estäisi tutkimukseen osallistumisen tai mutkistaisi tutkimustulosten tulkintaa, mukaan lukien sarveiskalvon dekompensaatio, joka ei reagoi lääketieteelliseen hoitoon ja mukaan lukien silmätaudit, jotka todennäköisesti vaativat kiellettyä hoitoa tutkimuksen aikana
  • Mikä tahansa vakava lääketieteellinen tila tai poikkeavuus kliinisissä laboratoriotutkimuksissa, joka tutkijan arvion mukaan estää henkilön turvallisen osallistumisen tutkimukseen ja sen loppuun saattamisen
  • raskaana tai imetys tai aikomus tulla raskaaksi tutkimuksen aikana tai 12 viikon sisällä viimeisen satralitsumabiannoksen jälkeen

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Satralitsumabi
Osan I jaksolla osallistujat saavat satralitsumabia 4 viikon välein (q4w), jota seuraa proptoosivasteeseen perustuva yksilöllinen hoito tutkimuksen osassa II
Lääke: Satralitsumabi
Satralitsumabi annetaan sc-injektiona.
Placebo Comparator: Plasebo
Osan I jaksolla osallistujat saavat lumelääkettä neljän viikon välein ja sitten proptoosivasteeseen perustuvaa yksilöllistä hoitoa tutkimuksen osassa II
Lääke: Plasebo
Plasebo annetaan SC-injektiona

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Aikaikkuna: 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
Aikaikkuna: At Week 24
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Aikaikkuna: At Week 24
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: At Week 48
At Week 48
Percentage of Participants Requiring Surgical Intervention for TED up to Week 48
Aikaikkuna: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Aikaikkuna: 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
Aikaikkuna: From Baseline to Week 48
From Baseline to Week 48
Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48
Aikaikkuna: Week 24, Week 48
Week 24, Week 48
Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48
Aikaikkuna: 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
Aikaikkuna: At Week 48
At Week 48
Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48
Aikaikkuna: 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
Aikaikkuna: From Week 24 to Week 48
From Week 24 to Week 48
Change in CAS From Week 24 to 48
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in CAS to Week 48
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up to Week 48
Up to Week 48

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hoffmann-La Roche

Tutkijat

  • Opintojohtaja: Clinical Trials, Hoffmann-La Roche

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 26. lokakuuta 2023

Ensisijainen valmistuminen (Todellinen)

Tiistai 8. heinäkuuta 2025

Opintojen valmistuminen (Todellinen)

Torstai 25. kesäkuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 5. heinäkuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 4. elokuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Maanantai 14. elokuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 31. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 7. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Pätevät tutkijat voivat pyytää pääsyä yksittäisten potilastason tietoihin pyyntöalustan (www.vivli.org) kautta. Lisätietoja Rochen tukikelpoisten opintojen kriteereistä on saatavilla täältä (https://vivli.org/ourmember/roche/).

Lisätietoja Rochen kliinisten tietojen jakamista koskevasta maailmanlaajuisesta käytännöstä ja siihen liittyvien kliinisten tutkimusten asiakirjojen pyytämisestä on täällä (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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