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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02047734
First received: January 26, 2014
Last updated: May 24, 2017
Last verified: May 2017
  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 0.5 mg Drug: RPC1063 1 mg Drug: RPC1063 placebo Drug: Interferon β-1a Drug: IFN β-1a placebo 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:
  • Annualized relase rate (ARR) at the end of Month 24 [ Time Frame: Month 24 ]

Estimated Enrollment: 1200
Actual Study Start Date: December 3, 2013
Study Completion Date: April 13, 2017
Primary Completion Date: March 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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 ClinicalTrials.gov identifier: 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 )
Study First Received: January 26, 2014
Last Updated: May 24, 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

ClinicalTrials.gov processed this record on September 19, 2017