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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 : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1320 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
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : April 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: RPC1063 0.5 mg
oral capsule, daily for 24 months
Other Name: Ozanimod
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
Experimental: RPC1063 1 mg
RPC1063 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Drug: RPC1063 1 mg
oral capsule, daily for 24 months
Other Name: Ozanimod
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
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
Drug: RPC1063 placebo
oral capsule, daily for 24 months
Drug: Interferon β-1a
intramuscular injection, 30 µg, weekly for 24 months
Other Name: Avonex



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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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
  • Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria:

  • Primary progressive multiple sclerosis

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

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: April 9, 2018
Last Verified: April 2018

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