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

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ClinicalTrials.gov Identifier: NCT02047734
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : May 30, 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 0.5 mg Drug: RPC1063 1 mg Drug: RPC1063 placebo Drug: Interferon β-1a Drug: IFN β-1a placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 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 : December 3, 2013
Primary Completion Date : March 27, 2017
Study Completion Date : April 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RPC1063 0.5 mg Drug: RPC1063 0.5 mg
oral capsule, daily for 24 months
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
Experimental: RPC1063 1 mg Drug: RPC1063 1 mg
oral capsule, daily for 24 months
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
Active Comparator: Interferon β-1a Drug: RPC1063 placebo
oral capsule, daily for 24 months
Drug: Interferon β-1a
intramuscular injection, 30 µg, weekly for 24 months


Outcome Measures

Primary Outcome Measures :
  1. Annualized relase rate (ARR) at the end of Month 24 [ Time Frame: Month 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:

  • 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): NCT02047734


  Show 299 Study Locations
Sponsors and Collaborators
Celgene
More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02047734     History of Changes
Other Study ID Numbers: RPC01-201-PartB
2012-002714-40 ( EudraCT Number )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 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
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic