Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003413-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Satralizumab Treatment | Experimental | Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| satralizumab | Drug | Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable & unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | Baseline up to 523 weeks |
| Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals, or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals, or antivirals and injection related reaction. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | Baseline up to 523 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) without Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, without Specific Plan; e-Active Suicidal Ideation with Specific Plan & Intent, f-Preparatory Acts & Behavior; g-Aborted Attempt; h-Interrupted Attempt; i-Actual Attempt(non-fatal); j-Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40743487 | Derived | Bennett JL, Fujihara K, Saiz A, Traboulsee AL, Greenberg BM, Weinshenker BG, Patti F, Kleiter I, Palace J, De Seze J, Evans R, Blondeau K, Klingelschmitt G, Vodopivec I, Rahim M, Yamamura T. Long-Term Efficacy and Safety of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder From the SAkuraMoon Open-Label Extension Study. Neurol Neuroimmunol Neuroinflamm. 2025 Sep;12(5):e200450. doi: 10.1212/NXI.0000000000200450. Epub 2025 Jul 31. |
Not provided
Not provided
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).
Not provided
Not provided
Not provided
Not provided
Participants from NCT02028884 and NCT02073279 enrolled in this study to receive satralizumab treatment. Participants were permitted to use azathioprine (AZA) or mycophenolate mofetil (MMF) or oral corticosteroids during the study as background immunosuppressive treatments.
A total of 119 participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 (NCT02028884) & BN40900 (NCT02073279) rolled over in study WN42349 at 53 sites in 17 countries. 'All Participants-treated population' is used to report results of this study, which includes 166 participants who received at least one dose of satralizumab at any time either during parent studies/this study, irrespective of enrollment in current study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Satralizumab | Participants rolled over from studies NCT02028884 and NCT02073279 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in this study. Participants who received at least 1 dose of satralizumab at any time during the parent studies or this study, irrespective of enrollment in current study are represented here. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| azathioprine (AZA) | Drug | Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day) |
|
|
| mycophenolate mofetil (MMF) | Drug | Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day |
|
|
| oral corticosteroids | Drug | Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day |
|
|
| Baseline up to 523 weeks |
| Number of Participants With Serious Infections and Hepatotoxicity | Hepatotoxicity was defined using the following Medical Dictionary for Regulatory Activities Standardised MedDRA Queries (MedDRA SMQs) - Cholestasis and jaundice of hepatic origin (SMQ narrow) and Drug related hepatic disorders - severe events only (SMQ narrow). The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279 ) was considered as baseline for this outcome measure. Data for all serious infections and hepatotoxicity from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | Baseline up to 523 weeks |
| Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | Time to first relapse (TFR) was defined as the time from randomization in parent studies to the first occurrence of the first iPDR. PDR=occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or NMOSD. New or worsening neurological symptoms that occur < 31 days following onset of PDR were considered part of same relapse. The time point of relapse onset=time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at the clinical cutoff date (CCOD) or at the time of withdrawal from study. The first dosing visit in current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline. All TFR data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline up to 528 weeks |
| iPDR-free Rate up to Week 456 | iPDR free rate was defined as the percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Percentages have been rounded off to the nearest decimal point. Kaplan-Meier method was used to estimate the iPDR-free rates. | Baseline up to Week 456 |
| Percentage of Relapse-Free Participants | Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any relapse events are reported here. Percentages have been rounded off to the nearest decimal point. | Baseline up to 528 weeks |
| Annualized Relapse Rate (ARR) | ARR was calculated as total number of relapses experienced divided by the participant-years of the whole study period. Adjusted ARR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to the first occurrence of the iPDR. PDR=occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New or worsening neurological symptoms that occur < 31 days following onset of a PDR were considered part of the same relapse. Time point of relapse onset=the time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). First dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All ARR data from time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline up to 528 weeks |
| Change in Expanded Disability Status Scale (EDSS) Score | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. Baseline is the last observation on or before the day of first study drug administration in the current study or the parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline and every 24 weeks (up to 528 weeks) |
| Time to First EDSS Scores Worsening | EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with a baseline score (BS) of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Participants were censored at date of last EDSS assessment or if no EDSS assessment was performed at randomization date. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. | Baseline up to 528 weeks |
| Event-free Rate for EDSS Score Worsening up to Week 456 | Event-free rate for EDSS score worsening was defined as the percentage of participants who did not experience worsening in their EDSS score from baseline. EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. Participants were censored at the date of the last EDSS assessment or if no EDSS assessment was performed at the randomization date. Baseline is defined as the last observation on/before the day of the first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates. | Baseline up to Week 456 |
| Percentage of Participants Without EDSS Worsening | EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with a BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any EDDS worsening events are reported here. Percentages have been rounded off to the nearest decimal point. | Baseline up to 528 weeks |
| Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Visual acuity is measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). Visual acuity scores (Snellen chart) worse than 20/200 [i.e. CF (counting fingers), HM (hand movement), LP (light perception), or NLP (no LP)] are converted to logMAR 1.85, logMAR 2.00, logMAR 2.70, and logMAR 3.00 respectively. LogMAR >= 1 is equivalent to Physically blind. A negative change from baseline indicates an improvement. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All VA data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline and every 24 weeks (up to 528 weeks) |
| Concentrations of Interleukin-6 (IL-6) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
| Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
| Concentration of C-Reactive Protein (CRP) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
| Serum Concentration of Satralizumab at Specified Timepoints | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528 |
| Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | The number and percentage of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants were participants with an ADA assay result at baseline. Post-baseline evaluable participants were participants with an ADA assay from at least one post-baseline sample. Participants positive for ADA= number of participants with positive ADA result. Participants negative for ADA=number of participants with negative or missing baseline ADA result(s) and all negative post-baseline results. Baseline was defined as last observation collected on or before day of first study drug administration in parent studies. All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | First dose of satralizumab in parent studies up to end of study WN42349 (up to 523 weeks) |
| Miami |
| Florida |
| 33136 |
| United States |
| Columbus Research and Wellness | Columbus | Georgia | 31909 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Consultants in Neurology Ltd | Northbrook | Illinois | 60062 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 64637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Wayne State University; UHC-4H | Detroit | Michigan | 48201 | United States |
| The Neurological Institute PA | Charlotte | North Carolina | 28204 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| Jefferson Hospital For Neuroscience; Jefferson Neurology Associates | Philadelphia | Pennsylvania | 19107 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-0001 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | 5800 | Bulgaria |
| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD | Sofia | 1113 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Aleksandrovska EAD | Sofia | 1431 | Bulgaria |
| MS Clinical Trials Group | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Centre hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | H2X 0A9 | Canada |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| Ruhr Universitat Bochum | Bochum | 44791 | Germany |
| Jahn Ferenc Del-Pesti Korhaz es Rendelointezet | Budapest | 1204 | Hungary |
| Azienda Ospedaliera Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | Sicily | 95123 | Italy |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Tokyo Women's Medical University Hospital | Tokyo | 162-8666 | Japan |
| National Center of Neurology and Psychiatry | Tokyo | 187-8551 | Japan |
| Hospital Kuala Lumpur | Kuala Lumpur | FED. Territory of Kuala Lumpur | 50586 | Malaysia |
| NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS | Katowice | 40-123 | Poland |
| M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM | Katowice | 40-571 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii | Lublin | 20-954 | Poland |
| Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii | Warsaw | 02-097 | Poland |
| Instytut Psychiatrii i Neurologii | Warsaw | 02-957 | Poland |
| Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw | 04-749 | Poland |
| San Juan MS Center | Guaynabo | 00968 | Puerto Rico |
| SC Clubul Sanatatii SRL | Campulung Muscel | 115100 | Romania |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| China Medical University Hospital | North Dist. | 40402 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70457 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Bilim University Medical Faculty Florence Nightingale Hospital | Istanbul | 34333 | Turkey (Türkiye) |
| Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council | Dnipro | Katerynoslav Governorate | 49069 | Ukraine |
| Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council | Odesa | Kherson Governorate | 65006 | Ukraine |
| Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC | Vinnytsia | Podolia Governorate | 21037 | Ukraine |
| Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC | Ternopil | Volhynian Governorate | 46027 | Ukraine |
| National Hospital For Neurology and Neurosurgery | London | WC1N 3BG | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Participants-treated population included all participants who received at least one dose of satralizumab at any time either during the parent studies or this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Satralizumab | Participants rolled over from studies NCT02028884 and NCT02073279 received satralizumab, 120 mg as SC injection, Q4W up to a maximum duration of 3 years in this study. Participants who received at least 1 dose of satralizumab at any time during the parent studies or this study, irrespective of enrollment in current study are represented here. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable & unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Count of Participants | Participants | Baseline up to 523 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals, or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals, or antivirals and injection related reaction. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Count of Participants | Participants | Baseline up to 523 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) without Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, without Specific Plan; e-Active Suicidal Ideation with Specific Plan & Intent, f-Preparatory Acts & Behavior; g-Aborted Attempt; h-Interrupted Attempt; i-Actual Attempt(non-fatal); j-Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | Posted | Count of Participants | Participants | Baseline up to 523 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Infections and Hepatotoxicity | Hepatotoxicity was defined using the following Medical Dictionary for Regulatory Activities Standardised MedDRA Queries (MedDRA SMQs) - Cholestasis and jaundice of hepatic origin (SMQ narrow) and Drug related hepatic disorders - severe events only (SMQ narrow). The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279 ) was considered as baseline for this outcome measure. Data for all serious infections and hepatotoxicity from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Count of Participants | Participants | Baseline up to 523 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | Time to first relapse (TFR) was defined as the time from randomization in parent studies to the first occurrence of the first iPDR. PDR=occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or NMOSD. New or worsening neurological symptoms that occur < 31 days following onset of PDR were considered part of same relapse. The time point of relapse onset=time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at the clinical cutoff date (CCOD) or at the time of withdrawal from study. The first dosing visit in current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline. All TFR data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 528 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | iPDR-free Rate up to Week 456 | iPDR free rate was defined as the percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Percentages have been rounded off to the nearest decimal point. Kaplan-Meier method was used to estimate the iPDR-free rates. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 456 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Relapse-Free Participants | Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any relapse events are reported here. Percentages have been rounded off to the nearest decimal point. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Number | percentage of participants | Baseline up to 528 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Annualized Relapse Rate (ARR) | ARR was calculated as total number of relapses experienced divided by the participant-years of the whole study period. Adjusted ARR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to the first occurrence of the iPDR. PDR=occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New or worsening neurological symptoms that occur < 31 days following onset of a PDR were considered part of the same relapse. Time point of relapse onset=the time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). First dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All ARR data from time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Posted | Number | 95% Confidence Interval | relapses per participant-year | Baseline up to 528 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Expanded Disability Status Scale (EDSS) Score | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. Baseline is the last observation on or before the day of first study drug administration in the current study or the parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 24 weeks (up to 528 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to First EDSS Scores Worsening | EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with a baseline score (BS) of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Participants were censored at date of last EDSS assessment or if no EDSS assessment was performed at randomization date. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 528 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Event-free Rate for EDSS Score Worsening up to Week 456 | Event-free rate for EDSS score worsening was defined as the percentage of participants who did not experience worsening in their EDSS score from baseline. EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. Participants were censored at the date of the last EDSS assessment or if no EDSS assessment was performed at the randomization date. Baseline is defined as the last observation on/before the day of the first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 456 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without EDSS Worsening | EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with a BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any EDDS worsening events are reported here. Percentages have been rounded off to the nearest decimal point. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | Baseline up to 528 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | Visual acuity is measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). Visual acuity scores (Snellen chart) worse than 20/200 [i.e. CF (counting fingers), HM (hand movement), LP (light perception), or NLP (no LP)] are converted to logMAR 1.85, logMAR 2.00, logMAR 2.70, and logMAR 3.00 respectively. LogMAR >= 1 is equivalent to Physically blind. A negative change from baseline indicates an improvement. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All VA data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | LogMAR units | Baseline and every 24 weeks (up to 528 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Interleukin-6 (IL-6) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/millilitre (pg/mL) | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/millilitre (ng/mL) | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Concentration of C-Reactive Protein (CRP) in Blood | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/litre (mg/L) | Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Satralizumab at Specified Timepoints | Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (NCT02028884/NCT02073279). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/litre (ng/L) | Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) From the First Dose of Satralizumab in Studies NCT02028884 or NCT02073279 | The number and percentage of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants were participants with an ADA assay result at baseline. Post-baseline evaluable participants were participants with an ADA assay from at least one post-baseline sample. Participants positive for ADA= number of participants with positive ADA result. Participants negative for ADA=number of participants with negative or missing baseline ADA result(s) and all negative post-baseline results. Baseline was defined as last observation collected on or before day of first study drug administration in parent studies. All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | First dose of satralizumab in parent studies up to end of study WN42349 (up to 523 weeks) |
|
Baseline up to 523 weeks
All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study. Participants from parent studies who did not enroll in the current study but received at least one dose satralizumab are also considered in this analysis set. The first dosing visit in the current study or the first satralizumab dosing visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Satralizumab | Participants rolled over from studies NCT02028884 and NCT02073279 received satralizumab, 120 mg as SC injection, Q4W up to a maximum duration of 3 years in this study. Participants who received at least 1 dose of satralizumab at any time during the parent studies or this study, irrespective of enrollment in current study are represented here. | 0 | 166 | 44 | 166 | 155 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic endocarditis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Limb fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuromyelitis optica pseudo relapse | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 27.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Complement factor C4 decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Dec 2, 2024 |
| Prot_SAP_000.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655944 | satralizumab |
| D001379 | Azathioprine |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Other |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|