Back to resultsAn Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Primary Purpose
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
eculizumab
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica focused on measuring Long-term safety study, Extension trial, Eculizumab, Neuromyelitis Optica Spectrum Disorder, Devic's disease, Transverse Myelitis, Optic Neuritis, Relapse, NMO-IgG, CNS Autoimmune Disorders, Demyelinating Disorders
Eligibility Criteria
Key Inclusion Criteria:
- Patient completed the ECU-NMO-301 trial
- Patient has given written informed consent
Key Exclusion Criteria:
- Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
- Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
Sites / Locations
- Mayo Clinic Arizona
- The Research Center of Southern California
- Georgetown University Hospital
- University of Miami McKnight Brain Institute
- Neurological Services of Orlando
- Allied Physicians Inc. of Fort Wayne
- University of Kansas Medical Center
- Baptist Health Lexington
- Johns Hopkins University Medical Center
- Mayo Clinic - Rochester
- Washington University School of Medicine
- Multiple Sclerosis Comprehensive Care Center NYU Langone Medical Center
- Mount Sinai School of Medicine
- Ohio Health Reserach Institute
- University of Pennsylvania School of Medicine
- University of Pittsburgh
- Multiple Sclerosis Treatment Center of Dallas
- The University of Texas Health Science
- University of Utah
- Hospital Universitario Austral
- Fundacion Rosarina de Neuro Rehabilitacion
- Hospital General de Agudos Dr. J. M. Ramos Mejia
- Hospital General de Agudos Juan Antonio Fernandez
- Brain and Mind Research Institute
- St. Vincent's Hospital
- The Ottawa Hospital
- Fundacion Cardiovascular de Colombia
- Clinical Hospital Centre Zagreb
- VFN v Praze
- Krajska zdravotni, a.s. - Nemocnice
- Århus Universitetshospital
- University Hospital Heidelberg
- Neurologische Klinik und Poliklinik
- University Hospital Heinrich Heine University
- Universitaetsmedizin Rostock
- Prince of Wales Hospital
- Policlinico di Catania
- Azienda Ospedaliera Universitaria
- Azienda Ospedaliera di Padova
- Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
- Chiba University Hospital
- Hyogo College of Medicine Hospital
- Kyoto Min-iren Chuo Hospital
- Tohoku University Hospital
- Yamaguchi University Hospital
- Kyushu University Hospital
- National Center Hospital, NCNP
- National Cancer Center
- Seoul University National Hospital
- Samsung Medical Center
- Korea University Anam Hospital
- Severance Hospital, Yonsei University
- Hospital Umum Sarawak
- Hospital Kuala Lumpur
- Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
- SBEI "Krasnoyarsk SMU n.a. Prof. V.F. Voyno-Yasenetsky"
- Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
- SEIHPE "Rostov SMU of MoH of RF"
- Hospital de Cruces
- Hospital Universitario Reina Sofia
- Hospital Universitario Clinico San Carlos
- Cheng Hsin General Hospital
- Thammasat University Hospital
- Hacettepe University Medical Faculty
- Trakya University Medical Faculty
- Dokuz Eylul University Medicine Faculty
- Kocaeli University Medical Faculty
- Ondokuz Mayis Univ. Med. Fac.
- The Walton Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eculizumab
Arm Description
Eculizumab intravenous infusion every two weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent adverse events (TEAEs) were defined as an AE with onset on or after the first study drug dose in Study ECU-NMO-302. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose either results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality
The C-SSRS is a validated questionnaire to capture occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Planned) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; and Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), and Completed Suicide. Suicidal Ideation or Behaviour: a "yes" answer to the following question: Self-injurious behaviour without suicidal intent.
Number of Participants With An On-trial Relapse as Determined by The Treating Physician
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician.
On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician
The On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period.
Secondary Outcome Measures
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Disease-related disability was measured by the EDSS. The EDSS quantifies disability in 8 Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. The Functional Systems are pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Change From Baseline in Modified Rankin Scale (mRS) Score
Disease-related disability was measured by the mRS score. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered from a neurological disability. The scale ranges from 0 (no symptoms at all) to 6 (death) in whole-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
The HAI evaluates gait and was used to assess the time and effort used by the participant to walk 25 feet (8 meters). The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully active) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). A decrease in score indicates improvement. Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
The EQ-5D is a generic, standardized participant self-administered health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analog scale (VAS) that allowed the participants to indicate their health state that ranged from 0 (worst imaginable) to 100 (best imaginable). Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
The EDSS assesses multiple Kurtzke functional systems in the context of a standard neurological exam, including visual function. The visual score ranges from 0 to 6. A score of 0 implies the participant has normal visual function. Higher scores represent worse disability. Baseline is defined as the last available assessment prior to the first study drug infusion in Study EC-NMO-302.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02003144
Brief Title
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Official Title
A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
Detailed Description
This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Keywords
Long-term safety study, Extension trial, Eculizumab, Neuromyelitis Optica Spectrum Disorder, Devic's disease, Transverse Myelitis, Optic Neuritis, Relapse, NMO-IgG, CNS Autoimmune Disorders, Demyelinating Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eculizumab
Arm Type
Experimental
Arm Description
Eculizumab intravenous infusion every two weeks.
Intervention Type
Biological
Intervention Name(s)
eculizumab
Other Intervention Name(s)
Soliris
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Description
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent adverse events (TEAEs) were defined as an AE with onset on or after the first study drug dose in Study ECU-NMO-302. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose either results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline up to end of study (up to 6.5 years)
Title
Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality
Description
The C-SSRS is a validated questionnaire to capture occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Planned) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; and Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), and Completed Suicide. Suicidal Ideation or Behaviour: a "yes" answer to the following question: Self-injurious behaviour without suicidal intent.
Time Frame
Baseline up to end of study (up to 6.5 years)
Title
Number of Participants With An On-trial Relapse as Determined by The Treating Physician
Description
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician.
Time Frame
Baseline up to end of study (up to 6.5 years)
Title
On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician
Description
The On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period.
Time Frame
Baseline up to end of study (up to 6.5 years)
Secondary Outcome Measure Information:
Title
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Description
Disease-related disability was measured by the EDSS. The EDSS quantifies disability in 8 Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. The Functional Systems are pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Time Frame
Baseline, Weeks 52, 104 and 156
Title
Change From Baseline in Modified Rankin Scale (mRS) Score
Description
Disease-related disability was measured by the mRS score. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered from a neurological disability. The scale ranges from 0 (no symptoms at all) to 6 (death) in whole-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Time Frame
Baseline, Weeks 52, 104 and 156
Title
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
Description
The HAI evaluates gait and was used to assess the time and effort used by the participant to walk 25 feet (8 meters). The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully active) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). A decrease in score indicates improvement. Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Time Frame
Baseline, Weeks 52, 104 and 156
Title
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
Description
The EQ-5D is a generic, standardized participant self-administered health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analog scale (VAS) that allowed the participants to indicate their health state that ranged from 0 (worst imaginable) to 100 (best imaginable). Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Time Frame
Baseline, Weeks 52, 104 and 156
Title
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
Description
The EDSS assesses multiple Kurtzke functional systems in the context of a standard neurological exam, including visual function. The visual score ranges from 0 to 6. A score of 0 implies the participant has normal visual function. Higher scores represent worse disability. Baseline is defined as the last available assessment prior to the first study drug infusion in Study EC-NMO-302.
Time Frame
Baseline, Weeks 52, 104 and 156
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Patient completed the ECU-NMO-301 trial
Patient has given written informed consent
Key Exclusion Criteria:
Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
The Research Center of Southern California
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami McKnight Brain Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Allied Physicians Inc. of Fort Wayne
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baptist Health Lexington
City
Nicholasville
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Johns Hopkins University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Multiple Sclerosis Comprehensive Care Center NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ohio Health Reserach Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Multiple Sclerosis Treatment Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas Health Science
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Fundacion Rosarina de Neuro Rehabilitacion
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BZL
Country
Argentina
Facility Name
Hospital General de Agudos Dr. J. M. Ramos Mejia
City
Ciudad Autonoma, Buenos Aires,
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital General de Agudos Juan Antonio Fernandez
City
Ciudad Autonoma, Buenos Aires
ZIP/Postal Code
C1425AGP
Country
Argentina
Facility Name
Brain and Mind Research Institute
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Fundacion Cardiovascular de Colombia
City
Floridablanca
State/Province
Santander
Country
Colombia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
VFN v Praze
City
Praha
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Nemocnice
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Århus Universitetshospital
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
University Hospital Heidelberg
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Neurologische Klinik und Poliklinik
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
University Hospital Heinrich Heine University
City
Dusseldorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Policlinico di Catania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
City
Rome
ZIP/Postal Code
00178
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba-Ken
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya-shi
State/Province
HyogoKen
Country
Japan
Facility Name
Kyoto Min-iren Chuo Hospital
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
604-8453
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube-shi
State/Province
Yamaguchi-Ken
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Center Hospital, NCNP
City
Tokio
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul University National Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
SBEI "Krasnoyarsk SMU n.a. Prof. V.F. Voyno-Yasenetsky"
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
City
Novosibirsk
ZIP/Postal Code
630068
Country
Russian Federation
Facility Name
SEIHPE "Rostov SMU of MoH of RF"
City
Rostov-on Don
Country
Russian Federation
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14404
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan
Facility Name
Thammasat University Hospital
City
Pathum Thani
Country
Thailand
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
Country
Turkey
Facility Name
Dokuz Eylul University Medicine Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
Country
Turkey
Facility Name
The Walton Centre
City
Liverpool
ZIP/Postal Code
L97LJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23623397
Citation
Pittock SJ, Lennon VA, McKeon A, Mandrekar J, Weinshenker BG, Lucchinetti CF, O'Toole O, Wingerchuk DM. Eculizumab in AQP4-IgG-positive relapsing neuromyelitis optica spectrum disorders: an open-label pilot study. Lancet Neurol. 2013 Jun;12(6):554-62. doi: 10.1016/S1474-4422(13)70076-0. Epub 2013 Apr 26.
Results Reference
background
PubMed Identifier
34498507
Citation
Pittock SJ, Fujihara K, Palace J, Berthele A, Kim HJ, Oreja-Guevara C, Nakashima I, Levy M, Shang S, Yountz M, Miller L, Armstrong R, Wingerchuk DM; PREVENT Study Group. Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension. Mult Scler. 2022 Mar;28(3):480-486. doi: 10.1177/13524585211038291. Epub 2021 Sep 9.
Results Reference
derived
PubMed Identifier
33676197
Citation
Kim HJ, Nakashima I, Viswanathan S, Wang KC, Shang S, Miller L, Yountz M, Wingerchuk DM, Pittock SJ, Levy M, Berthele A, Totolyan N, Palace J, Barnett MH, Fujihara K; PREVENT Study Group. Eculizumab in Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder: A subgroup analysis from the randomized phase 3 PREVENT trial and its open-label extension. Mult Scler Relat Disord. 2021 May;50:102849. doi: 10.1016/j.msard.2021.102849. Epub 2021 Feb 20.
Results Reference
derived
Learn more about this trial
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
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