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Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628393
First Posted: June 26, 2012
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose
The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).

Condition Intervention Phase
Relapsing Multiple Sclerosis Drug: RPC1063 Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ]

Enrollment: 258
Actual Study Start Date: September 18, 2012
Study Completion Date: May 3, 2016
Primary Completion Date: April 15, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC1063 Low Dose Drug: RPC1063
oral, low dose, daily for 24 weeks
Placebo Comparator: placebo Drug: placebo
oral, 1 capsule, daily for 24 weeks
Experimental: RPC1063 High Dose Drug: RPC1063
oral, high dose, daily for 24 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
  • EDSS score between 0 and 5.0 at baseline

Exclusion Criteria:

  • Secondary or primary progressive multiple sclerosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628393


  Hide Study Locations
Locations
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705
Neuro Pain Medical Center
Fresno, California, United States, 93710
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, North Carolina
The Neurological Institute PA
Charlotte, North Carolina, United States, 28204
United States, Ohio
Neurology and Neuroscience Associates Inc.
Akron, Ohio, United States, 44320
United States, Washington
The Polyclinic
Seattle, Washington, United States, 98104
Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Centre Hospitalier Chretien Clinique Saint Joseph
Montegnee, Belgium, 4420
Clinique Saint-Pierre
Ottignies, Belgium, 1340
Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, Bulgaria, 1431
Georgia
Sarajishvili Institute of Neurology
Tbilisi, Georgia, 0112
LTD MediClubGeorgia
Tbilisi, Georgia, 0160
Khechinashvili University Hospital
Tbilisi, Georgia, 0179
Greece
Evaggelismos General Hospital
Athens, Greece, 10676
401 Military Hospital of Athens
Athens, Greece, 11525
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Vaszary Kolos Korhaz
Esztergom, Hungary, 2500
Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Cantania, Italy, 95123
Poland
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
Czeladz, Poland, 41-250
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziadz, Poland, 86-300
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Poland, 40-650
NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, Poland, 40-749
NEURO MEDIC Janusz Zbrojkiewicz
Katowice, Poland, 40-752
RESMEDICA Spolka z o.o.
Kielce, Poland, 25-726
Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
Konstancin Jeziorna, Poland, 05-510
Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
Lublin, Poland, 20-718
Centrum Neurologii Krzysztof Selmaj
Lódzkie, Poland, 90-324
Wojewodzki Szpital Specjalistyczny
Olsztyn, Poland, 10-561
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
Plewiska, Poland, 62-064
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
Podlaskie, Poland, 15-402
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, Poland, 61-853
EUROMEDIS Sp. z.o.o.
Szczecin, Poland, 70-111
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
Warminsko-mazurskie, Poland, 10-443
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Warsaw, Poland, 00-739
Centralny Szpital Kliniczny MSWIA
Warsaw, Poland, 02-507
Wojskowy Instytut Medyczny
Warszawa, Poland, 00-909
Instytut Psychiatrii i Neurologii
Warszawa, Poland, 02-957
Romania
Health Club Medical Center S.R.L.
Campulung, Romania, 115100
Rehabilitation Clinical Hospital
Cluj-Napoca, Romania, 400347
Colentina Clinical Hospital
Napoca, Romania, 400001
Timisoara Emergency County Clinical Hospital
Timisoara, Romania, 300736
Russian Federation
Republican Clinical Hospital for Rehabilitation Treatment
Kazan, Russian Federation, 420021
Research Medical Complex Vashe Zdorovie
Kazan, Russian Federation, 420097
City Clinical Hospital 4
Saransk, Russian Federation, 430032
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Centar Zvezdara
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinical Hospital Centre Zemun
Belgrade, Serbia, 11080
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Spain
Hospital Donostia
San Sebastian, Spain, 20014
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Ukraine
Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
Chernigiv, Ukraine, 14033
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
Dnipropetrovsk, Ukraine, 49027
Regional Clinical Hospital
Ivano Frankivsk, Ukraine, 76008
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, Ukraine, 61103
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, Ukraine, 04107
Volyn Regional Clinical Hospital
Lutsk, Ukraine, 43024
Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
Vinnytsya, Ukraine, 21005
Sponsors and Collaborators
Celgene
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01628393     History of Changes
Other Study ID Numbers: RPC01-201-PartA
2012-002714-40 ( EudraCT Number )
First Submitted: June 22, 2012
First Posted: June 26, 2012
Last Update Posted: July 31, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases