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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004092-39 | EudraCT Number | ||
| 2023-507817-85-00 | EU Trial (CTIS) Number |
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This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Participants with body weight ≥10kg to <20kg | Experimental | Satralizumab will be administered SC Q6W in a cohort of at least 2 evaluable patients |
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| Cohort 2 Participants with body weight ≥20kg to <40kg | Experimental | Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter. |
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| Cohort 3 Participants with body weight ≥40kg | Experimental | Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satralizumab | Drug | Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of observed serum concentration [Cthrough] of satralizumab | Week 48 | |
| Apparent clearance [CL/F] of satralizumab | Week 48 | |
| Apparent volume of distribution [V/F] of satralizumab | Week 48 | |
| Area under the concentration-time curve [AUC] of satralizumab | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of relapse-free patients by Week 48 | Week 48 | |
| Annualized relapse rate (ARR), defined as the average number of relapses for each year of the study | Week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WN41733 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact | global.medical_information@roche.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado. | Recruiting | Denver | Colorado | 80218-1007 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Time to first relapse (TFR) after randomization, defined as the time from randomization until the first occurrence of relapse, as determined by the investigator |
| Week 48 |
| Time to relapse requiring rescue therapy | Week 48 |
| Change from baseline in Expanded Disability Status Scale (EDSS) at Weeks 24 and 48 | Baseline, Week 24, Week 48 |
| Change from baseline in visual acuity at Weeks 24 and 48 | Baseline, Week 24, Week 48 |
| Change from baseline in FACES Pain Rating Scale at Weeks 24 and 48 | Baseline, Week 24, Week 48 |
| Change from baseline in EuroQol 5-Dimension, Youth (EQ-5D-Y) score and its proxy at Weeks 24 and 48 | Baseline, Week 24, Week 48 |
| Incidence and severity of adverse events | Week 48 |
| Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan |
| Recruiting |
| Ciudad Autonoma Buenos Aires |
| C1249ABN |
| Argentina |
| Clinica Universitaria Reina Fabiola | Recruiting | Córdoba | X5004FHP | Argentina |
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | 510120 | China |
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
| Centre Hospitalier Universitaire de Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
| IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN | Recruiting | Rome | Lazio | 00165 | Italy |
| Fondazione Istituto Neurologico Mondino IRCCS | Recruiting | Pavia | Lombardy | 27100 | Italy |
| Grupo Medico Camino | Recruiting | DF | Mexico CITY (federal District) | DUMMY_VALUE | Mexico |
| Uniwersyteckie Centrum Kliniczne | Active, not recruiting | Gdansk | 80-214 | Poland |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Recruiting | Warsaw | 04-730 | Poland |
| Kocaeli University Research and Application Hospit | Recruiting | Kocaeli | 6810 | Turkey (Türkiye) |
| Great Ormond Street Hospital for Children | Recruiting | London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000655944 | satralizumab |
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