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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000253-36 | EudraCT Number |
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To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.
Inebilizumab is a genetically engineered humanized monoclonal antibody that binds to the B cell specific surface antigen cluster of differentiation (CD19) resulting in the depletion of B cells. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells, which are generally CD19 positive and CD20 negative.
The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD.
This is a multicenter, multinational, randomized, double-masked, placebo controlled study with an open-label extension period to evaluate the efficacy and safety of intravenous (IV) inebilizumab in adult participants with NMO/NMOSD. After a screening period, eligible participants will enter a randomized-controlled period (RCP) of maximum 197 days where they will be randomized in a 3:1 ratio to receive either IV inebilizumab or placebo. NMO/NMOSD attacks will be evaluated by the investigator and confirmed against the attack criteria by an independent Adjudication Committee (AC). Participants for whom the attack was confirmed by the AC will be given the option to enroll into an open label period (OLP) with inebilizumab treatment. Participants who complete the RCP without experiencing an attack will be given the option to enroll into an OLP with inebilizumab treatment. The OLP will continue for a minimum of 1 year and a maximum of 3 years after the last participant enter the OLP. All participants who discontinue from the RCP or the OLP will continue in a Safety Follow-up for a total of 12 months from last dose to evaluate the long-term safety of the investigational product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Inebilizumab | Placebo Comparator | Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug. |
|
| Inebilizumab/Inebilizumab | Experimental | AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inebilizumab | Drug | Participants will receive IV inebilizumab 300 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP | The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis. | Day 1 (Baseline) through Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP | EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more. |
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Inclusion Criteria:
Men and women 18 years or older with diagnosis of NMO/NMOSD
Confirmation of NMO/NMOSD status:
Able and willing to give written informed consent and comply with the requirements of the study protocol.
EDSS <= 7.5 (8 in special circumstances)
Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
Exclusion Criteria:
Lactating and pregnant females
Treatment with any investigational agent within 4 weeks of screening
Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
Receipt of the following at any time prior to randomization:
Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
Receipt of any of the following within 3 months prior to randomization:
History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune, LLC MedImmune, LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222408 | Derived | Bennett JL, Pittock SJ, Paul F, Kim HJ, Irani SR, O'Connor KC, Patterson KR, Smith MA, Gunsior M, Mittereder N, Rees WA, Cimbora D, Cree BAC. B cell and aquaporin-4 antibody relationships with neuromyelitis optica spectrum disorder activity. Ann Clin Transl Neurol. 2024 Oct;11(10):2792-2798. doi: 10.1002/acn3.52171. Epub 2024 Sep 2. | |
| 38760098 |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Inebilizumab | Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized-controlled Period (RCP) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2018 | Oct 24, 2019 |
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| Placebo | Other | Participants will receive IV placebo matched to inebilizumab. |
|
| Day 1 (Baseline) through Day 197 |
| Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP | Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision. | Day 1 (Baseline) through Day 197 |
| Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP | The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord. | From Screening (Day -28) to Day 197 |
| Number of NMOSD-related In-patient Hospitalizations During RCP | Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission. | Day 1 (Baseline) through Day 197 |
| Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab | Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported. | For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP. | Day 1 (Baseline) through Day 197 |
| Number of Participants With TEAEs and TESAEs During OLP | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. | Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
| Number of Participants With TEAEs and TESAEs During SFP (Open-label Population) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP. | Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) |
| Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP. | Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) |
| Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP | Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported. | Day 1 (Baseline) through Day 197 |
| Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP | Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported. | Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
| Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) | Time to maximum serum concentration of inebilizumab during RCP is reported. | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
| Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) | Maximum observed serum concentration of inebilizumab during RCP is reported. | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
| Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) | Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported. | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) | Number of participants with positive ADA titer to inebilizumab during RCP is reported. | Pre and post dose on Day 1; and on Days 29, 85, and 197 |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP) | Number of participants with positive ADA titer to inebilizumab in OLP is reported. | Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
| Sacramento |
| California |
| 95817 |
| United States |
| Research Site | San Francisco | California | 94158 | United States |
| Research Site | Aurora | Colorado | 80010 | United States |
| Research Site | New Haven | Connecticut | 06511 | United States |
| Research Site | Maitland | Florida | 32751 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63131-2374 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45219 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Mansfield | Ohio | 44906 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Richmond | Virginia | 23298 | United States |
| Research Site | Melbourne | 3065 | Australia |
| Research Site | Sofia | 1113 | Bulgaria |
| Research Site | Sofia | 1309 | Bulgaria |
| Research Site | Sofia | 1431 | Bulgaria |
| Research Site | Varna | 9010 | Bulgaria |
| Research Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Research Site | Barranquilla | 080020 | Colombia |
| Research Site | Bogotá | 110131 | Colombia |
| Research Site | Bogotá | 110231 | Colombia |
| Research Site | Cali | 760032 | Colombia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 121 11 | Czechia |
| Research Site | Teplice | 415 29 | Czechia |
| Research Site | Tallinn | 10617 | Estonia |
| Research Site | Tartu | 51014 | Estonia |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Rostock | 18147 | Germany |
| Research Site | Hong Kong | Hong Kong |
| Research Site | Esztergom | 2500 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Szeged | 6725 | Hungary |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Ramat Gan | 52621 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Aomori | 030-8553 | Japan |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Kyoto | 604-8453 | Japan |
| Research Site | Ōta-ku | 145-0065 | Japan |
| Research Site | Sendai | 980-8574 | Japan |
| Research Site | Tsukuba | 305-8577 | Japan |
| Research Site | Mexico City | 03310 | Mexico |
| Research Site | Mexico City | 14269 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | San Luis Potosí City | 78090 | Mexico |
| Research Site | Chisinau | 2028 | Moldova |
| Research Site | Auckland | 1023 | New Zealand |
| Research Site | Bellavista | CALLAO 2 | Peru |
| Research Site | Lima | LIMA 01 | Peru |
| Research Site | Katowice | 40-595 | Poland |
| Research Site | Krakow | 31-637 | Poland |
| Research Site | Lódz | 90-324 | Poland |
| Research Site | Lublin | 20-954 | Poland |
| Research Site | Olsztyn | 10-560 | Poland |
| Research Site | Warsaw | 02-097 | Poland |
| Research Site | Warsaw | 02-957 | Poland |
| Research Site | Belgorod | 308007 | Russia |
| Research Site | Kazan' | 420021 | Russia |
| Research Site | Khabarovsk | 680009 | Russia |
| Research Site | Krasnoyarsk | 660037 | Russia |
| Research Site | Moscow | 123367 | Russia |
| Research Site | Moscow | 127018 | Russia |
| Research Site | Nizhny Novgorod | 603155 | Russia |
| Research Site | Novosibirsk | 63007 | Russia |
| Research Site | Omsk | 644033 | Russia |
| Research Site | Saint Petersburg | 197110 | Russia |
| Research Site | Ufa | 450005 | Russia |
| Research Site | Belgrade | 11129 | Serbia |
| Research Site | Cape Town | 7505 | South Africa |
| Research Site | Cape Town | 7925 | South Africa |
| Research Site | Goyang | 410-769 | South Korea |
| Research Site | Jongno-gu | 110-744 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 143729 | South Korea |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Changhua | 50006 | Taiwan |
| Research Site | Hualien City | 97002 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Muang | 40002 | Thailand |
| Research Site | Muang | 50200 | Thailand |
| Research Site | Istanbul | 34098 | Turkey (Türkiye) |
| Research Site | Istanbul | 34147 | Turkey (Türkiye) |
| Research Site | Istanbul | 34890 | Turkey (Türkiye) |
| Research Site | Izmir | 35170 | Turkey (Türkiye) |
| Research Site | Samsun | 55139 | Turkey (Türkiye) |
| Cree BAC, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, She D, Rees W, Smith M, Cimbora D, Katz E, Bennett JL; N-MOmentum study investigators. Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial. Lancet Neurol. 2024 Jun;23(6):588-602. doi: 10.1016/S1474-4422(24)00077-2. |
| 37221052 | Derived | Aktas O, Hartung HP, Smith MA, Rees WA, Fujihara K, Paul F, Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Cutter G, She D, Gunsior M, Cimbora D, Katz E, Cree BA; N-MOmentum study investigators. Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder. J Neurol Neurosurg Psychiatry. 2023 Sep;94(9):757-768. doi: 10.1136/jnnp-2022-330412. Epub 2023 May 23. |
| 36370634 | Derived | Bennett JL, Aktas O, Rees WA, Smith MA, Gunsior M, Yan L, She D, Cimbora D, Pittock SJ, Weinshenker BG, Paul F, Marignier R, Wingerchuk D, Cutter G, Green A, Hartung HP, Kim HJ, Fujihara K, Levy M, Katz E, Cree BAC; N-MOmentum study investigators. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial. EBioMedicine. 2022 Dec;86:104321. doi: 10.1016/j.ebiom.2022.104321. Epub 2022 Nov 10. |
| 35158461 | Derived | Flanagan EP, Levy M, Katz E, Cimbora D, Drappa J, Mealy MA, She D, Cree BAC. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022 Jan;57:103352. doi: 10.1016/j.msard.2021.103352. Epub 2021 Oct 26. |
| 33771837 | Derived | Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Green AJ, Aktas O, Hartung HP, Lublin FD, Williams IM, Drappa J, She D, Cimbora D, Rees W, Smith M, Ratchford JN, Katz E, Cree BAC; N-MOmentum Study Investigators. Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 26;8(3):e978. doi: 10.1212/NXI.0000000000000978. Print 2021 May. |
| 33724534 | Derived | Aktas O, Smith MA, Rees WA, Bennett JL, She D, Katz E, Cree BAC; N-MOmentum scientific group and the N-MOmentum study investigators. Serum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker. Ann Neurol. 2021 May;89(5):895-910. doi: 10.1002/ana.26067. Epub 2021 Mar 30. |
| 33538237 | Derived | Cree BA, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Williams IM, Drappa J, She D, Cimbora D, Rees W, Ratchford JN, Katz E. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD. Mult Scler. 2021 Nov;27(13):2052-2061. doi: 10.1177/1352458521988926. Epub 2021 Feb 4. |
| 31495497 | Derived | Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5. |
| 26666258 | Derived | Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14. |
| FG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Open-label Period (OLP) |
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The Intent-to-treat (ITT) population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Inebilizumab | Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
| BG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP | The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | Days | Day 1 (Baseline) through Day 197 |
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| Secondary | Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP | EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. | Posted | Number | Percentage of Participants | Day 1 (Baseline) through Day 197 |
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| Secondary | Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP | Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with low contrast visual acuity binocular score were analyzed for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on scale | Day 1 (Baseline) through Day 197 |
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| Secondary | Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP | The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with observed MRI lesions were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Number of lesions | From Screening (Day -28) to Day 197 |
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| Secondary | Number of NMOSD-related In-patient Hospitalizations During RCP | Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with in-patient hospitalization were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Number of In-patient Hospitalizations | Day 1 (Baseline) through Day 197 |
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| Secondary | Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab | Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported. | Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP. | Posted | Number | Annualized attack rate | For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP. | As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received. | Posted | Count of Participants | Participants | Day 1 (Baseline) through Day 197 |
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| Secondary | Number of Participants With TEAEs and TESAEs During OLP | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. | Open-label population included all participants who received at least one dose of inebilizumab during OLP. | Posted | Count of Participants | Participants | Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
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| Secondary | Number of Participants With TEAEs and TESAEs During SFP (Open-label Population) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP. | Open-label population included all participants who received at least one dose of inebilizumab during OLP. | Posted | Count of Participants | Participants | Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) |
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| Secondary | Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP. | Non-OLP population included all participants who received any dose of study drug, analyzed according to the treatment received in RCP, but did not roll over to OLP. | Posted | Count of Participants | Participants | Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) |
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| Secondary | Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP | Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported. | As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received. 'Number of Participants analyzed' signifies participants who were analyzed for this outcome measure. | Posted | Count of Participants | Participants | Day 1 (Baseline) through Day 197 |
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| Secondary | Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP | Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported. | Open-label population included all participants who received at least one dose of study drug during OLP. | Posted | Count of Participants | Participants | Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
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| Secondary | Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) | Time to maximum serum concentration of inebilizumab during RCP is reported. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2). | Posted | Median | Full Range | Days | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) | Maximum observed serum concentration of inebilizumab during RCP is reported. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
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| Secondary | Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) | Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*d/mL | Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) | Number of participants with positive ADA titer to inebilizumab during RCP is reported. | The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies the number of participants who had adequate ADA samples. | Posted | Count of Participants | Participants | Pre and post dose on Day 1; and on Days 29, 85, and 197 |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP) | Number of participants with positive ADA titer to inebilizumab in OLP is reported. | Open-label population included all participants who received at least one dose of inebilizumab during OLP. 'Number analyzed' signifies the number of participants who had adequate ADA samples. | Posted | Count of Participants | Participants | Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) |
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From Day 1 through the end of study (approximately 5 years 10 months)
Adverse events are reported for all 3 study periods combined (RCP, OLP, and SFP).
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 | Placebo/Inebilizumab | Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. | 1 | 56 | 24 | 56 | 48 | 56 |
| EG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. | 2 | 174 | 28 | 174 | 138 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Renal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Optic neuritis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Peripheral nerve palsy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Calculus bladder | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Deafness | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
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| Steroid withdrawal syndrome | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
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| Blindness unilateral | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Central nervous system infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Chorioretinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Hepatitis a | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Meningitis viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Neuroborreliosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Progressive multifocal leukoencephalopat | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pyelonephritis chronic | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Burns third degree | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Lumbosacral radiculopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Myelitis transverse | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Neuromyelitis optica spectrum disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Post cardiac arrest syndrome | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Unresponsive to stimuli | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Uraemic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Drug reaction with eosinophilia and syst | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Shock | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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In the safety follow-up period (SFP), only 1 participant from 'Placebo/Inebilizumab' arm rolled over to SFP and no participant from 'Inebilizumab /Inebilizumab' arm rolled over to SFP. For EudraCT result posting, a study period with any one of the arm with zero participants started is not acceptable (EudraCT limitation). Therefore, not included SFP in 'Participant Flow' section to keep the data consistent across registry portals.
Viela Bio has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multicentre publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical study Information Center | +1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2018 | Oct 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| D003711 | Demyelinating Diseases |
| 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 |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609745 | inebilizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Other |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
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AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
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| OG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
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| OG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
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| OG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
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| OG001 | Inebilizumab/Inebilizumab | AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug. |
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| Participants |
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