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

This study has been completed.
Information provided by (Responsible Party):
Celgene Identifier:
First received: June 22, 2012
Last updated: May 23, 2017
Last verified: May 2017
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: 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
Study Start Date: July 2012
Study Completion Date: April 2016
Primary Completion Date: April 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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628393

  Hide Study Locations
United States, California
Berkeley, California, United States
Fresno, California, United States
United States, Ohio
Akron, Ohio, United States
United States, Washington
Seattle, Washington, United States
Montegnée, Belgium
Sofia, Bulgaria
Tbilisi, Georgia
Athens, Greece
Thessaloniki, Greece
Esztergom, Hungary
Catania, Italy
Bialystok, Poland
Czeladz, Poland
Grudziadz, Poland
Katowice, Poland
Kielce, Poland
Konstancin-Jeziorna, Poland
Lodz, Poland
Lublin, Poland
Olsztyn, Poland
Plewiska, Poland
Poznan, Poland
Szczecin, Poland
Warszawa, Poland
Bucharest, Romania
Campulung, Romania
Cluj-Napoca, Romania
Timisoara, Romania
Russian Federation
Kazan, Russian Federation
Saransk, Russian Federation
Belgrade, Serbia
Beograd, Serbia
Kragujevac, Serbia
San Sebastián, Spain
Valencia, Spain
Ivano-Frankivsk, Vinnytsya, Ukraine
Chernihiv, Ukraine
Dnipropetrovsk, Ukraine
Lutsk, Ukraine
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Celgene Identifier: NCT01628393     History of Changes
Other Study ID Numbers: RPC01-201-PartA
2012-002714-40 ( EudraCT Number )
Study First Received: June 22, 2012
Last Updated: May 23, 2017

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on July 21, 2017