Back to resultsA Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
Primary Purpose
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eculizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica focused on measuring Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Devic's disease, Transverse Myelitis, Optic Neuritis, relapse, eculizumab, soliris, NMO-IgG, CNS Autoimmune Disorders, Demyelinating Disorders, NMO, NMOSD
Eligibility Criteria
Key Inclusion Criteria:
- Male or female participants ≥ 18 years old.
- Diagnosis of NMO or NMOSD.
- AQP4 antibody seropositive.
- Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
- Expanded Disability Status Scale score ≤ 7.
- If a participant entered the study receiving immunosuppressive therapy (IST) for relapse prevention, the participant must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to Screening and must have remained on that dose for the duration of the study, unless the participant experienced a relapse.
- Female participants of childbearing potential were to have a negative pregnancy test (serum human chorionic gonadotropin). Participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.
Key Exclusion Criteria:
- Use of rituximab within 3 months prior to Screening.
- Use of mitoxantrone within 3 months prior to Screening.
- Use of intravenous immunoglobulin within 3 weeks prior to Screening.
Sites / Locations
- Mayo Clinic Arizona
- The Research Center of Southern California
- Georgetown University Hospital
- University of Miami McKnight Brain Institute
- Neurological Services of Orlando
- Fort Wayne Neurological Center
- University of Kansas Medical Center
- Baptist Health Lexington
- University of Maryland Medical Center
- John Hopkins University School of Medicine
- Mayo Clinic - Rochester
- Washington University School of Medicine
- Multiple Sclerosis Comprehensive Care Center, NYU Langone Medical Center
- The Ohio State University, Wexner Medical Center, CarePoint at Gahanna
- Hospital of the University of Pennsylvania
- University of Pittsburgh
- Multiple Sclerosis Treatment Center of Dallas
- University of Utah Health Care
- Swedish Neuroscience Institute
- Hospital General de Agudos Juan Antonio Fernandez
- Hospital J. M. Ramos Mejia
- Hospital Universitario Austral
- Fundacion Rosarina de Neuro Rehabilitacion
- University of Sydney, Brain and Mind Center
- St. Vincent's Hospital Melbourne
- Clinical Hospital Centre Zagreb
- Vseobecna fakultni nemocnice Neurologicka klinika
- Århus Universitetshospital
- Universitaetsklinikum Heidelberg, Abteilung Neuroonkologie
- Klinikum rechts der Isar der TU Muenchen, Neurologische Klinik und Poliklinik
- Universitaetsmedizin Rostock, Klinik für Neurologie
- Prince of Wales Hospital
- Universitaria Policlinico di Catania
- Azienda Ospedaliera Universitaria Federico II
- Azienda Ospedaliera San Camillo Forlanini
- Neurological Centre of Latium Dipartimento di Neuroscienze
- Chiba University Hospital
- Hyogo College of Medicine Hospital
- Kyoto Min-iren Chuo Hospital
- Tohoku University Hospital
- Tokyo Medical and Dental University
- Yamaguchi University Hospital
- Kyushu University Hospital
- National Center Hospital, NCNP
- National Cancer Center
- Korea University Anam Hospital
- Seoul University National Hospital
- Severance Hospital, Yonsei University
- Samsung Medical Center
- Hospital Kuala Lumpur
- Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
- FSBHI 'Siberian Clinical Center of FMBA'
- Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
- SBEIHPE "Rostov SMU of MoH of RF"
- First Pavlov State Medical University of St.Petersburg
- Hospital de Cruces
- Hospital Universitario Reina Sofia
- Hospital Universitario Clinico San Carlos
- Cheng Hsin General Hospital
- Navamindradhiraj University, Vajira Hospital
- Thammasat University Hospital
- Sunprasitthiprasong Hospital
- Hacettepe University Medical Faculty
- Istanbul University Cerrahpasa Medical Faculty
- Istanbul Bilim Universty Medical Fac.
- Dokuz Eylul University Medicine Faculty
- Kocaeli University Medical Faculty
- Ondokuz Mayis Univ. Med. Fac.
- The Walton Centre
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Eculizumab
Placebo
Arm Description
Biological/Vaccine: Eculizumab; Induction Period: Participants received eculizumab (900 milligrams [mg]) via intravenous (IV) infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Placebo contains the same buffer components without the active ingredient. Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Outcomes
Primary Outcome Measures
Participants With An Adjudicated On-trial Relapse
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. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.
Secondary Outcome Measures
Adjudicated On-trial Annualized Relapse Rate (ARR)
The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of patient years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Change From Baseline In EDSS At End Of Study
Disease-related disability was measured by the EDSS. 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.
Change From Baseline In Modified Rankin Scale (mRS) Score At End Of Study
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 disability) to 6 (death) in whole-point increments. A decrease in score indicates improvement.
Change From Baseline In Hauser Ambulation Index (HAI) Score At End of Study
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 ambulatory with no assistance) and 9 being the worst (restricted to wheel chair; unable to transfer self independently). A decrease in score indicates improvement.
Change From Baseline In European Quality Of Life (EuroQoL) Health 5-Dimension Questionnaire (EQ-5D) Visual Analogue Scale At End Of Study
The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Assessments were made using the EQ-5D Visual Analogue Scale, which captures the self-rating of current health status using a visual "thermometer" with the endpoints of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom. An increase in score indicates improvement.
Change From Baseline In EuroQoL EQ-5D Index Score At End Of Study
The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Index scores range from less than 0 to 1, with higher scores representing a better health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01892345
Brief Title
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Study Start Date
April 11, 2014 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (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 objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
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
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Devic's disease, Transverse Myelitis, Optic Neuritis, relapse, eculizumab, soliris, NMO-IgG, CNS Autoimmune Disorders, Demyelinating Disorders, NMO, NMOSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eculizumab
Arm Type
Experimental
Arm Description
Biological/Vaccine: Eculizumab; Induction Period: Participants received eculizumab (900 milligrams [mg]) via intravenous (IV) infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo contains the same buffer components without the active ingredient. Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Intervention Type
Drug
Intervention Name(s)
Eculizumab
Other Intervention Name(s)
Soliris
Intervention Description
Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
Primary Outcome Measure Information:
Title
Participants With An Adjudicated On-trial Relapse
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. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Secondary Outcome Measure Information:
Title
Adjudicated On-trial Annualized Relapse Rate (ARR)
Description
The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of patient years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Title
Change From Baseline In EDSS At End Of Study
Description
Disease-related disability was measured by the EDSS. 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.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Title
Change From Baseline In Modified Rankin Scale (mRS) Score At End Of Study
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 disability) to 6 (death) in whole-point increments. A decrease in score indicates improvement.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Title
Change From Baseline In Hauser Ambulation Index (HAI) Score At End of Study
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 ambulatory with no assistance) and 9 being the worst (restricted to wheel chair; unable to transfer self independently). A decrease in score indicates improvement.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Title
Change From Baseline In European Quality Of Life (EuroQoL) Health 5-Dimension Questionnaire (EQ-5D) Visual Analogue Scale At End Of Study
Description
The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Assessments were made using the EQ-5D Visual Analogue Scale, which captures the self-rating of current health status using a visual "thermometer" with the endpoints of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom. An increase in score indicates improvement.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
Title
Change From Baseline In EuroQoL EQ-5D Index Score At End Of Study
Description
The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Index scores range from less than 0 to 1, with higher scores representing a better health status.
Time Frame
Baseline, Up To 211 Weeks (End of Study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female participants ≥ 18 years old.
Diagnosis of NMO or NMOSD.
AQP4 antibody seropositive.
Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
Expanded Disability Status Scale score ≤ 7.
If a participant entered the study receiving immunosuppressive therapy (IST) for relapse prevention, the participant must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to Screening and must have remained on that dose for the duration of the study, unless the participant experienced a relapse.
Female participants of childbearing potential were to have a negative pregnancy test (serum human chorionic gonadotropin). Participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.
Key Exclusion Criteria:
Use of rituximab within 3 months prior to Screening.
Use of mitoxantrone within 3 months prior to Screening.
Use of intravenous immunoglobulin within 3 weeks prior to Screening.
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
Carlsbad
State/Province
California
ZIP/Postal Code
92011
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
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
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
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John Hopkins University School of Medicine
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
The Ohio State University, Wexner Medical Center, CarePoint at Gahanna
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Hospital of the University of Pennsylvania
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
15213
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
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Hospital General de Agudos Juan Antonio Fernandez
City
Ciudad Autonoma, Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hospital J. M. Ramos Mejia
City
Ciudad Autonoma, Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1221
Country
Argentina
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
University of Sydney, Brain and Mind Center
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vseobecna fakultni nemocnice Neurologicka klinika
City
Praha
ZIP/Postal Code
128 21
Country
Czechia
Facility Name
Århus Universitetshospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Universitaetsklinikum Heidelberg, Abteilung Neuroonkologie
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen, Neurologische Klinik und Poliklinik
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsmedizin Rostock, Klinik für Neurologie
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Universitaria Policlinico di Catania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
Neurological Centre of Latium Dipartimento di Neuroscienze
City
Rome
ZIP/Postal Code
00178
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kyoto Min-iren Chuo Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
604-8453
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tokyo Medical and Dental University
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube-shi
State/Province
Yamaguchi
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
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul University National Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
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
FSBHI 'Siberian Clinical Center of FMBA'
City
Krasnoyarsk
ZIP/Postal Code
630037
Country
Russian Federation
Facility Name
Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
City
Novosibirsk
ZIP/Postal Code
630067
Country
Russian Federation
Facility Name
SBEIHPE "Rostov SMU of MoH of RF"
City
Rostov-on Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
First Pavlov State Medical University of St.Petersburg
City
St. Petersburg
ZIP/Postal Code
197022
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
14011
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
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Navamindradhiraj University, Vajira Hospital
City
Dusit
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Thammasat University Hospital
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Sunprasitthiprasong Hospital
City
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul Bilim Universty Medical Fac.
City
Istanbul
ZIP/Postal Code
34381
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
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
The Walton Centre
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
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
31050279
Citation
Pittock SJ, Berthele A, Fujihara K, Kim HJ, Levy M, Palace J, Nakashima I, Terzi M, Totolyan N, Viswanathan S, Wang KC, Pace A, Fujita KP, Armstrong R, Wingerchuk DM. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019 Aug 15;381(7):614-625. doi: 10.1056/NEJMoa1900866. Epub 2019 May 3.
Results Reference
result
PubMed Identifier
34803867
Citation
Singh P, Gao X, Kleijn HJ, Bellanti F, Pelto R. Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Neuromyelitis Optica Spectrum Disorder. Front Neurol. 2021 Nov 3;12:696387. doi: 10.3389/fneur.2021.696387. eCollection 2021.
Results Reference
derived
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
PubMed Identifier
33310418
Citation
Palace J, Wingerchuk DM, Fujihara K, Berthele A, Oreja-Guevara C, Kim HJ, Nakashima I, Levy M, Terzi M, Totolyan N, Viswanathan S, Wang KC, Pace A, Yountz M, Miller L, Armstrong R, Pittock S; PREVENT Study Group. Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial. Mult Scler Relat Disord. 2021 Jan;47:102641. doi: 10.1016/j.msard.2020.102641. Epub 2020 Nov 26.
Results Reference
derived
Links:
URL
http://www.alexionclinicaltrials.com
Description
Alexion Clinical Trials Website
Learn more about this trial
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
We'll reach out to this number within 24 hrs