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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01628393
Other study ID # RPC01-201-PartA
Secondary ID 2012-002714-40
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 18, 2012
Est. completion date May 11, 2016

Study information

Verified date January 2021
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date May 11, 2016
Est. primary completion date April 13, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Intervention

Drug:
Ozanimod
Oral capsule taken once a day
Placebo
Oral capsule taken once a day

Locations

Country Name City State
Belgium Cliniques Universitaires St-Luc Brussels
Belgium Centre Hospitalier Chretien Clinique Saint Joseph Montegnee
Belgium Clinique Saint-Pierre Ottignies
Bulgaria University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD Sofia
Georgia Khechinashvili University Hospital Tbilisi
Georgia LTD MediClubGeorgia Tbilisi
Georgia Sarajishvili Institute of Neurology Tbilisi
Greece 401 Military Hospital of Athens Athens
Greece Evaggelismos General Hospital Athens
Greece Georgios Papanikolaou General Hospital of Thessaloniki Thessaloniki
Hungary Vaszary Kolos Korhaz Esztergom
Italy Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Cantania
Poland Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi Czeladz
Poland Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Grudziadz
Poland NEURO MEDIC Janusz Zbrojkiewicz Katowice
Poland NEURO- CARE Site Management Organization Gabriela Klodowska-Duda Katowice
Poland Novo-Med Zielinski i wsp. Sp.J. Katowice
Poland RESMEDICA Spolka z o.o. Kielce
Poland Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny Konstancin Jeziorna
Poland Centrum Neurologii Krzysztof Selmaj Lódzkie
Poland Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny Lublin
Poland Wojewodzki Szpital Specjalistyczny Olsztyn
Poland Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska Plewiska
Poland Niepubliczny Zaklad Opieki Zdrowotnej KENDRON Podlaskie
Poland Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy Poznan
Poland EUROMEDIS Sp. z.o.o. Szczecin
Poland Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski Warminsko-mazurskie
Poland Centralny Szpital Kliniczny MSWIA Warsaw
Poland Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej Warsaw
Poland Instytut Psychiatrii i Neurologii Warszawa
Poland Wojskowy Instytut Medyczny Warszawa
Romania Health Club Medical Center S.R.L. Campulung
Romania Rehabilitation Clinical Hospital Cluj-Napoca
Romania Colentina Clinical Hospital Napoca
Romania Timisoara Emergency County Clinical Hospital Timisoara
Russian Federation Republican Clinical Hospital for Rehabilitation Treatment Kazan
Russian Federation Research Medical Complex Vashe Zdorovie Kazan
Russian Federation City Clinical Hospital 4 Saransk
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Centar Zvezdara Belgrade
Serbia Clinical Hospital Centre Zemun Belgrade
Serbia Military Medical Academy Belgrade
Serbia Clinical Center Kragujevac Kragujevac
Spain Hospital Donostia San Sebastian
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Ukraine Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital Chernigiv
Ukraine Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov Dnipropetrovsk
Ukraine Regional Clinical Hospital Ivano Frankivsk
Ukraine State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya Kharkiv
Ukraine Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Kyiv
Ukraine Volyn Regional Clinical Hospital Lutsk
Ukraine Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko Vinnytsya
United States Neurology and Neuroscience Associates Inc. Akron Ohio
United States Alta Bates Summit Medical Center Berkeley California
United States The Neurological Institute PA Charlotte North Carolina
United States Neuro Pain Medical Center Fresno California
United States University of California Davis Medical Center Sacramento California
United States The Polyclinic Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Georgia,  Greece,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Ukraine, 

References & Publications (2)

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 (RADIAN — View Citation

Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdová EK, Cree BA, Montalbán X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extens — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
Secondary The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24 MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. Week 24
Secondary The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24 The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24.
MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24
Secondary Adjusted Annualized Relapse Rate (ARR) at Week 24 A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for > 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of = 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on = two functional system scale scores.
Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study * 365.
ARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.
Week 24
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.
The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.
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.
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24.
Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.
The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.
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.
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