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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
June 22, 2012
June 26, 2012
July 31, 2017
September 18, 2012
April 15, 2014   (Final data collection date for primary outcome measure)
Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ]
  • Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ]
  • Annualized relapse rate [ Time Frame: Month 24 ]
Complete list of historical versions of study NCT01628393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study)
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
The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • Drug: RPC1063
    oral, low dose, daily for 24 weeks
  • Drug: placebo
    oral, 1 capsule, daily for 24 weeks
  • Drug: RPC1063
    oral, high dose, daily for 24 weeks
  • Experimental: RPC1063 Low Dose
    Intervention: Drug: RPC1063
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: RPC1063 High Dose
    Intervention: Drug: RPC1063
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
May 3, 2016
April 15, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   Georgia,   Greece,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Ukraine,   United States
 
 
NCT01628393
RPC01-201-PartA
2012-002714-40 ( EudraCT Number )
Yes
Not Provided
Not Provided
Celgene
Celgene
Not Provided
Not Provided
Celgene
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP