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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT01628393
First received: June 22, 2012
Last updated: June 7, 2016
Last verified: June 2016
  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
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

  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:

  • 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 ClinicalTrials.gov identifier: NCT01628393

  Show 39 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 (Part A)
2012-002714-40 ( EudraCT Number )
Study First Received: June 22, 2012
Last Updated: June 7, 2016

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

ClinicalTrials.gov processed this record on April 28, 2017