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

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ClinicalTrials.gov Identifier: NCT01628393
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE June 22, 2012
First Posted Date  ICMJE June 26, 2012
Results First Submitted Date  ICMJE January 25, 2021
Results First Posted Date  ICMJE February 11, 2021
Last Update Posted Date February 11, 2021
Actual Study Start Date  ICMJE September 18, 2012
Actual Primary Completion Date April 13, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 [ Time Frame: From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24 ]
The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2012)
  • Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ]
  • Annualized relapse rate [ Time Frame: Month 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24 [ Time Frame: Week 24 ]
    MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
  • The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24 [ Time Frame: Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24 ]
    The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
  • Adjusted Annualized Relapse Rate (ARR) at Week 24 [ Time Frame: Week 24 ]
    A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for > 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study * 365. ARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.
  • Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period [ Time Frame: From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period. ]
    An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes. The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.
  • Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure [ Time Frame: From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively. ]
    AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes. The investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.
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 Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
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

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with 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: Ozanimod
    Oral capsule taken once a day
    Other Names:
    • RPC1063
    • Zeposia®
  • Drug: Placebo
    Oral capsule taken once a day
Study Arms  ICMJE
  • Experimental: Ozanimod 0.5 mg
    Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.
    Intervention: Drug: Ozanimod
  • Experimental: Ozanimod 1 mg
    Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.
    Intervention: Drug: Ozanimod
  • Placebo Comparator: Placebo
    Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
    Interventions:
    • Drug: Ozanimod
    • Drug: Placebo
Publications *

*   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: June 7, 2016)
258
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2012)
1110
Actual Study Completion Date  ICMJE May 11, 2016
Actual Primary Completion Date April 13, 2014   (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:

  • Secondary or 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 Belgium,   Bulgaria,   Georgia,   Greece,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01628393
Other Study ID Numbers  ICMJE RPC01-201-PartA
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 January 2021

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