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Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis (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: NCT02047734
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE January 26, 2014
First Posted Date  ICMJE January 28, 2014
Last Update Posted Date April 9, 2018
Actual Study Start Date  ICMJE December 3, 2013
Actual Primary Completion Date March 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Annualized relapse rate (ARR) at the end of Month 24 [ Time Frame: Month 24 ]
The relapse rate was based on only relapses that were confirmed by the treating investigator. Any new or recurrent neurological symptoms that occurred less than 30 days following the onset of a protocol defined relapse was considered part of the same relapse, i.e., if 2 relapses have onset days that are <30 days of one another, were counted as 1 relapse with onset date as the earlier of the 2 relapses.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2014)
Annualized relase rate (ARR) at the end of Month 24 [ Time Frame: Month 24 ]
Change History Complete list of historical versions of study NCT02047734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • The number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months [ Time Frame: Up to 24 months ]
    The number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since baseline from Week 12 to Week 24.
  • The number of GdE brain MRI lesions at Month 24 [ Time Frame: Up to months 24 ]
    The number of Gd-enhancing T1-lesions per MRI scan was measured as the total number of Gd-enhancing T1-lesions that occurred at month 24. Includes participants with non-missing MRI results and included to the analysis population.
  • Time to onset of disability progression as defined by a sustained worsening in EDSS of 1.0 points or more, confirmed after 3 months and after 6 months [ Time Frame: Up to month 6 ]
    The Expanded Disability Status Scale (EDSS) is an ordinal scale instrument widely accepted to evaluate disability status at a particular time and disability progression over time in patients and MS clinical studies. The disability level is based on a neurological examination to obtain scores in seven neurologic functional systems (FSs) and an ambulation score that are combined to determine the overall EDSS score (step) ranging from 0 (normal) to 10 (death due to MS). The FSs are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral. Ambulation is measured based on if restriction is present and assisted required as well as minimum distance level achieved.
  • Proportion of patients who are GdE lesion-free at Month 24 [ Time Frame: Up to month 24 ]
    Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions from the date of the first study treatment to their month 24 MRI Scan.
  • Proportion of patients who are new or enlarging T2 lesion-free at Month 24 [ Time Frame: Month 24 ]
    Participants were considered T2 lesion free at Month 24 if they did not show evidence of a relapse in T2 lesions from the date of the first study treatment to study completion at month 24.
  • The percent change in normalized brain volume (atrophy) on brain MRI scans from baseline to [ Time Frame: Baseline to month 24 ]
    Brain volumes were reported in cm^3. Atrophy was measured by MRI scan.
  • Change in MSFC score from Baseline to Month 24 (including the Low-Contrast Letter Acuity [ Time Frame: Up to month 24 ]
    The MSFC-LCLA is a battery including the following 4 individual scales:
    • The Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds
    • The 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function
    • The Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability
    • Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity Z-scores were calculated for the MSFC for each component and averaged to create an overall composite score. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
  • Change in MSQOL-54 score from Baseline to Month 24 [ Time Frame: At month 24 ]
    The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each domain has a range from 0 to 100 where higher means better or improved.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis (Radiance Study)
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE
  • Drug: RPC1063 0.5 mg
    oral capsule, daily for 24 months
    Other Name: Ozanimod
  • Drug: RPC1063 1 mg
    oral capsule, daily for 24 months
    Other Name: Ozanimod
  • Drug: RPC1063 placebo
    oral capsule, daily for 24 months
  • Drug: Interferon β-1a
    intramuscular injection, 30 µg, weekly for 24 months
    Other Name: Avonex
  • Drug: IFN β-1a placebo
    intramuscular injection, weekly for 24 months
Study Arms  ICMJE
  • Experimental: RPC1063 0.5 mg
    RPC1063 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
    Interventions:
    • Drug: RPC1063 0.5 mg
    • Drug: IFN β-1a placebo
  • Experimental: RPC1063 1 mg
    RPC1063 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
    Interventions:
    • Drug: RPC1063 1 mg
    • Drug: IFN β-1a placebo
  • Active Comparator: Interferon β (IFN)
    IFN β-1a 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to RPC 1063) orally daily for 24 months
    Interventions:
    • Drug: RPC1063 placebo
    • Drug: Interferon β-1a
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
1320
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2014)
1200
Actual Study Completion Date  ICMJE April 13, 2017
Actual Primary Completion Date March 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria:

  • Primary progressive multiple sclerosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Georgia,   Greece,   Hungary,   Italy,   Moldova, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02047734
Other Study ID Numbers  ICMJE RPC01-201-PartB
2012-002714-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celgene
Verification Date April 2018

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