Clinical trial NCT01628393: Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
Official title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).


Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline

Exclusion Criteria:

* Secondary or primary progressive multiple sclerosis

Primary outcomes:
measure: Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24
timeFrame: From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
Secondary outcomes:
measure: The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24
timeFrame: Week 24
measure: The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24
timeFrame: Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
measure: Adjusted Annualized Relapse Rate (ARR) at Week 24
timeFrame: Week 24
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period
timeFrame: From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure
timeFrame: From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively.
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Charlotte
country: United States
facility: The Neurological Institute PA
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates Inc.
state: Ohio
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Montegnee
country: Belgium
facility: Centre Hospitalier Chretien Clinique Saint Joseph
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Tbilisi
country: Georgia
facility: Sarajishvili Institute of Neurology
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: Khechinashvili University Hospital
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Esztergom
country: Hungary
facility: Vaszary Kolos Korhaz
city: Cantania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Czeladz
country: Poland
facility: Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
city: Katowice
country: Poland
facility: Novo-Med Zielinski i wsp. Sp.J.
city: Katowice
country: Poland
facility: NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
city: Katowice
country: Poland
facility: NEURO MEDIC Janusz Zbrojkiewicz
city: Kielce
country: Poland
facility: RESMEDICA Spolka z o.o.
city: Konstancin Jeziorna
country: Poland
facility: Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
city: Lublin
country: Poland
facility: Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
city: Lódzkie
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
city: Podlaskie
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z.o.o.
city: Warminsko-mazurskie
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
city: Warsaw
country: Poland
facility: Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWIA
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Campulung
country: Romania
facility: Health Club Medical Center S.R.L.
city: Cluj-Napoca
country: Romania
facility: Rehabilitation Clinical Hospital
city: Napoca
country: Romania
facility: Colentina Clinical Hospital
city: Timisoara
country: Romania
facility: Timisoara Emergency County Clinical Hospital
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital for Rehabilitation Treatment
city: Kazan
country: Russian Federation
facility: Research Medical Complex Vashe Zdorovie
city: Saransk
country: Russian Federation
facility: City Clinical Hospital 4
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Chernigiv
country: Ukraine
facility: Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
city: Ivano Frankivsk
country: Ukraine
facility: Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Vinnytsya
country: Ukraine
facility: Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
Study officials:
References:
citation: Cohen JA, Arnold DL, Comi G, Bar-Or A, Gujrathi S, Hartung JP, Cravets M, Olson A, Frohna PA, Selmaj KW; RADIANCE Study Group. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):373-81. doi: 10.1016/S1474-4422(16)00018-1. Epub 2016 Feb 12.
citation: Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdova EK, Cree BA, Montalban X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study. Mult Scler. 2019 Aug;25(9):1255-1262. doi: 10.1177/1352458518789884. Epub 2018 Jul 25.