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Safety and Efficacy of Fingolimod in MS Patients in China

Primary Purpose

Multiple Sclerosis (Relapsing Remitting)

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
fingolimod
Placebo (6mos) + open label fingolimod (6 mos)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (Relapsing Remitting) focused on measuring multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Patients must have relapsing remitting multiple sclerosis

Exclusion Criteria:

Patients with:

  • History of chronic immune disease
  • Certain cancers
  • Uncontrolled diabetes
  • Certain eye disorders -Negative for varicella
  • zoster virus IgG antibodies
  • Certain hepatic conditions
  • Low white blood cell count
  • On certain immunosuppressive medications or heart medications
  • Certain heart conditions or certain lung conditions
  • Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
  • Other protocol defined inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    double blinded Fingolimod 6 mos + open label fingolimod 6 mos

    Placebo 6 mos + open label fingolimod 6 mos

    Arm Description

    Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

    Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

    Outcomes

    Primary Outcome Measures

    number of new/newly enlarged T2 MRI lesions over 6 months
    Cumulative number of new/newly enlarged T2 lesions over 6 months

    Secondary Outcome Measures

    annualized relapse rate (ARR)
    The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study.
    number of Gd-enhancing T1 lesions
    Safety and tolerability of fingolimod 0.5 mg compared to placebo
    Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities

    Full Information

    First Posted
    September 9, 2013
    Last Updated
    April 20, 2017
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01941004
    Brief Title
    Safety and Efficacy of Fingolimod in MS Patients in China
    Official Title
    A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis (Relapsing Remitting)
    Keywords
    multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    double blinded Fingolimod 6 mos + open label fingolimod 6 mos
    Arm Type
    Experimental
    Arm Description
    Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
    Arm Title
    Placebo 6 mos + open label fingolimod 6 mos
    Arm Type
    Placebo Comparator
    Arm Description
    Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
    Intervention Type
    Drug
    Intervention Name(s)
    fingolimod
    Intervention Description
    Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (6mos) + open label fingolimod (6 mos)
    Intervention Description
    Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
    Primary Outcome Measure Information:
    Title
    number of new/newly enlarged T2 MRI lesions over 6 months
    Description
    Cumulative number of new/newly enlarged T2 lesions over 6 months
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    annualized relapse rate (ARR)
    Description
    The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study.
    Time Frame
    6 months
    Title
    number of Gd-enhancing T1 lesions
    Time Frame
    6 months
    Title
    Safety and tolerability of fingolimod 0.5 mg compared to placebo
    Description
    Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Patients must have relapsing remitting multiple sclerosis Exclusion Criteria: Patients with: History of chronic immune disease Certain cancers Uncontrolled diabetes Certain eye disorders -Negative for varicella zoster virus IgG antibodies Certain hepatic conditions Low white blood cell count On certain immunosuppressive medications or heart medications Certain heart conditions or certain lung conditions Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica. Other protocol defined inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Fingolimod in MS Patients in China

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