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A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention (SAkuraBonsai)

Primary Purpose

Neuromyelitis Optica Spectrum Disorder, NMOSD

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Satralizumab 120 mg
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Age 18 to 74 years, inclusive, at the time of informed consent
  • Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
  • For women of childbearing potential: agreement to either remain abstinent (refrain from heterosexual intercourse) or to use reliable means of contraception (physical barrier [patient or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug Cohort 1 (treatment-naïve NMOSD patients)
  • Confirmation of NMOSD diagnosis with AQP4+ antibodies
  • Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last year prior to screening
  • Naive to maintenance therapy (disease-modifying therapy [DMT] or immunosuppressive therapy [IST]) Cohort 2 (NMOSD patients with inadequate response to RTX [or its biosimilar])
  • Confirmation of NMOSD diagnosis and AQP4+ antibodies in the disease history of the patient
  • Have a length of disease duration from first symptom of ≤5 years
  • History of ongoing treatment with RTX (or its biosimilar) (at least 2 infusions) for NMOSD with a maximum duration of 6 months since last administration prior to enrolment in the study
  • Ongoing disease activity after last RTX (or its biosimilar) infusion i.e., relapse and/or any new inflammatory event, confirmed by magnetic resonance imaging (MRI) or ophthalmological assessment

Exclusion criteria Exclusion criteria for both the cohorts

  • Inability to complete an MRI
  • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
  • Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
  • Evidence of other demyelinating disease, including MS or progressive multifocal leukoencephalopathy (PML)
  • Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
  • Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection or other infection (excluding fungal infections of nail beds or caries dentium) at baseline
  • Infection requiring hospitalization or treatment with intravenous (IV) anti-infective agents within 4 weeks prior to baseline visit
  • Evidence of chronic active hepatitis B
  • Evidence of active tuberculosis (TB)
  • History or laboratory evidence of coagulation disorders
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
  • Presence or history of malignancy
  • History of drug or alcohol abuse within 1 year prior to baseline
  • History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
  • History of severe allergic reaction to a biologic agent
  • Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
  • Treatment with any investigational agent within 6 months prior to baseline or 5 drug elimination half-lives of the investigational agent (whichever is longer) Cohort 1 (treatment-naïve NMOSD patients)
  • Any previous treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, stem-cell therapy, or bone marrow transplantation
  • Any previous treatment with eculizumab, belimumab, natalizumab, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, siponimod, or ozanimod
  • Any previous treatment with anti-CD4, cladribine or mitoxantrone
  • Any previous treatment with B-cell depleting agents
  • Any previous treatment with immunosuppressants Cohort 2 (NMOSD patients with inadequate response to RTX)
  • Discontinued RTX (or biosimilar) treatment due to any other reason than inadequate response to treatment

Sites / Locations

  • Stanford Health Care
  • University Of Colorado
  • University of Kansas Medical Center
  • Massachusetts General Hospital
  • Thomas Jefferson University
  • University of Texas Southwestern Medical Center
  • Medical College of Wisconsin
  • Montreal Neurological Institute and Hospital
  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • Hopital La Pitie Salpetriere
  • CHU Strasbourg Hôpital Hautepierre
  • CHU de Toulouse - Hôpital Purpan
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
  • Universitatsklinikum Munster
  • Deenanath Mangeshkar Hospital & Research Centre
  • Azienda Ospedaliera Sant'AndreaRecruiting
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • Chiba University HospitalRecruiting
  • Southern Tohoku Medical ClinicRecruiting
  • National Cancer Center
  • Seoul National University Hospital
  • Hacettepe University Medical Faculty; Neurology
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Kocaeli University Hospital; Department of Neurology
  • Ondokuz Mayis University School of Medicine; NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: treatment-naïve NMOSD patients

Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTX

Arm Description

Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).

Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).

Outcomes

Primary Outcome Measures

Proportion of relapse-free patients
Annualized relapse rate (ARR)
Time to first relapse (TFR)
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability.
Time to onset of confirmed disability progression (CDP) sustained for at least 12 weeks and 24 weeks
Change from baseline in the Symbol Digital Modalities Test (SDMT) over the course of the study
Change in high-contrast (100%) and lowcontrast (2.5%) visual acuity using appropriate high-and low-contrast letter acuity (LCLA) charts over the course of the study
Proportion of participants hospitalized due to relapse
Proportion of participants using corticosteroids due to relapse
Proportion of participants in need of rescue therapy due to relapse
Proportion of participants in need of plasma exchange due to relapse
Proportion of participants with disability (measured by Expanded Disability Status Scale EDSS) due to relapse

Secondary Outcome Measures

Count, volume and regional distribution of T2-weighted fluid-attenuated inversion-recovery (FLAIR) hyperintense lesions
Including new and enlarging lesions of the cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum; Fazekas scoring
Global and regional brain volume loss including basal ganglia, cerebellum and upper cervical spinal cord.
New and persisting short T1 inversion recovery (STIR)/Proton Density (PD) hyperintense lesions and T1-weighted contrast enhancement
Quantitative T1 mapping (magnetizationprepared rapid gradient echo sequence [MP2RAGE])
Quantitative diffusion/diffusion tensor imaging (DTI)
Change in the retinal nerve fiber layer (RNFL) thickness
Change in the ganglion cell plus inner plexiform (GCIP) layer thickness
Incidence and severity of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs)

Full Information

First Posted
February 15, 2022
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical Co.
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1. Study Identification

Unique Protocol Identification Number
NCT05269667
Brief Title
A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Acronym
SAkuraBonsai
Official Title
SAkuraBonsai: Clinical, Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 29, 2026 (Anticipated)
Study Completion Date
January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical Co.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)
Detailed Description
Neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD) are severe demyelinating inflammatory autoimmune neurological disorders. The estimated global pooled prevalence of NMOSD is 1.82 per 100 000 people (Etemadifar et al. 2015). The disorder is characterized by inflammatory lesions in the optic nerve, spinal cord, brainstem, and cerebrum; and clinically by optic neuritis (ON) and/or transverse myelitis causing potentially severe motor and sensory impairment, bladder dysfunction, vision loss, pain, and other debilitating symptoms (Wingerchuk et al. 2015). Recovery is variable, and inflammatory attacks often result in permanent disability. Untreated, the risks of severe disability or death are substantial (Jarius et al. 2014). NMOSD is radiologically and prognostically distinct from multiple sclerosis (MS), and has a pathophysiology unresponsive to typical MS treatment (Weinshenker 2007; Oh, and Levy et al. 2012).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorder, NMOSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: treatment-naïve NMOSD patients
Arm Type
Experimental
Arm Description
Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).
Arm Title
Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTX
Arm Type
Experimental
Arm Description
Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).
Intervention Type
Drug
Intervention Name(s)
Satralizumab 120 mg
Intervention Description
Satralizumab 120 mg will be administered as monotherapy (SC) in the abdominal or femoral region at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Weeks 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).
Primary Outcome Measure Information:
Title
Proportion of relapse-free patients
Time Frame
Up to Week 96
Title
Annualized relapse rate (ARR)
Time Frame
Up to Week 96
Title
Time to first relapse (TFR)
Time Frame
Up to Week 96
Title
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
Description
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability.
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Time to onset of confirmed disability progression (CDP) sustained for at least 12 weeks and 24 weeks
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Change from baseline in the Symbol Digital Modalities Test (SDMT) over the course of the study
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Change in high-contrast (100%) and lowcontrast (2.5%) visual acuity using appropriate high-and low-contrast letter acuity (LCLA) charts over the course of the study
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Proportion of participants hospitalized due to relapse
Time Frame
Up to Week 96
Title
Proportion of participants using corticosteroids due to relapse
Time Frame
Up to Week 96
Title
Proportion of participants in need of rescue therapy due to relapse
Time Frame
Up to Week 96
Title
Proportion of participants in need of plasma exchange due to relapse
Time Frame
Up to Week 96
Title
Proportion of participants with disability (measured by Expanded Disability Status Scale EDSS) due to relapse
Time Frame
Up to Week 96
Secondary Outcome Measure Information:
Title
Count, volume and regional distribution of T2-weighted fluid-attenuated inversion-recovery (FLAIR) hyperintense lesions
Description
Including new and enlarging lesions of the cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum; Fazekas scoring
Time Frame
Up to Week 96
Title
Global and regional brain volume loss including basal ganglia, cerebellum and upper cervical spinal cord.
Time Frame
At Screening, Weeks 48 and 96
Title
New and persisting short T1 inversion recovery (STIR)/Proton Density (PD) hyperintense lesions and T1-weighted contrast enhancement
Time Frame
Up to Week 96
Title
Quantitative T1 mapping (magnetizationprepared rapid gradient echo sequence [MP2RAGE])
Time Frame
Up to Week 96
Title
Quantitative diffusion/diffusion tensor imaging (DTI)
Time Frame
Up to Week 96
Title
Change in the retinal nerve fiber layer (RNFL) thickness
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Change in the ganglion cell plus inner plexiform (GCIP) layer thickness
Time Frame
Baseline (Day -28 to Day -1) to Week 96
Title
Incidence and severity of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs)
Time Frame
Up to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age 18 to 74 years, inclusive, at the time of informed consent Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria For women of childbearing potential: agreement to either remain abstinent (refrain from heterosexual intercourse) or to use reliable means of contraception (physical barrier [patient or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug Cohort 1 (treatment-naïve NMOSD patients) Confirmation of NMOSD diagnosis with AQP4+ antibodies Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last year prior to screening Naive to maintenance therapy (disease-modifying therapy [DMT] or immunosuppressive therapy [IST]) Cohort 2 (NMOSD patients with inadequate response to RTX [or its biosimilar]) Confirmation of NMOSD diagnosis and AQP4+ antibodies in the disease history of the patient Have a length of disease duration from first symptom of ≤5 years History of ongoing treatment with RTX (or its biosimilar) (at least 2 infusions) for NMOSD with a maximum duration of 6 months since last administration prior to enrolment in the study Ongoing disease activity after last RTX (or its biosimilar) infusion i.e., relapse and/or any new inflammatory event, confirmed by magnetic resonance imaging (MRI) or ophthalmological assessment Exclusion criteria Exclusion criteria for both the cohorts Inability to complete an MRI Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline Evidence of other demyelinating disease, including MS or progressive multifocal leukoencephalopathy (PML) Evidence of serious uncontrolled concomitant diseases that may preclude patient participation Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection or other infection (excluding fungal infections of nail beds or caries dentium) at baseline Infection requiring hospitalization or treatment with intravenous (IV) anti-infective agents within 4 weeks prior to baseline visit Evidence of chronic active hepatitis B Evidence of active tuberculosis (TB) History or laboratory evidence of coagulation disorders Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline Presence or history of malignancy History of drug or alcohol abuse within 1 year prior to baseline History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation History of severe allergic reaction to a biologic agent Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening Treatment with any investigational agent within 6 months prior to baseline or 5 drug elimination half-lives of the investigational agent (whichever is longer) Cohort 1 (treatment-naïve NMOSD patients) Any previous treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, stem-cell therapy, or bone marrow transplantation Any previous treatment with eculizumab, belimumab, natalizumab, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, siponimod, or ozanimod Any previous treatment with anti-CD4, cladribine or mitoxantrone Any previous treatment with B-cell depleting agents Any previous treatment with immunosuppressants Cohort 2 (NMOSD patients with inadequate response to RTX) Discontinued RTX (or biosimilar) treatment due to any other reason than inadequate response to treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MN42928, https://forpatients.roche.com/
Phone
888-662-6728 (U.S.)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-0001
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Withdrawn
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU Strasbourg Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Withdrawn
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Southern Tohoku Medical Clinic
City
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

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