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

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.
ClinicalTrials.gov Identifier: NCT01628393
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: RPC1063 Drug: placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
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
Actual Study Start Date : September 18, 2012
Primary Completion Date : April 15, 2014
Study Completion Date : May 3, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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


  Show 58 Study Locations
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 Posted: June 26, 2012    Key Record Dates
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