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Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS (STAY)

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
individualized patient support program
Standard care
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients eligible for inclusion in this trial have to fulfill all of the following criteria:

  1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
  2. Male or female subjects aged 18 - 65 years.
  3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
  4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
  5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

  1. Patients, who are registered in any patient support program (e.g. Extracare)
  2. Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
  3. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
  4. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  5. Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
  6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum)
  7. Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details).
  8. Simultaneous participation in another clinical trial.

Patients, who have already been randomized into this trial earlier must not be included a second time.

Study personnel or first degree relatives of investigator(s) must not be included in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    1 standard care

    2 individualized PSP

    Arm Description

    standard care

    individualized patient support program

    Outcomes

    Primary Outcome Measures

    change in treatment satisfaction (TSQM-9) from baseline to month 6
    To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.

    Secondary Outcome Measures

    change in Modified Morisky Scale score from baseline to month 6
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    quantification of therapy adherence (pill-count) over 6 months
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill-count in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    change in mFIS score from baseline to month 6
    To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    change in BDI from baseline to month 6
    To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.

    Full Information

    First Posted
    October 16, 2012
    Last Updated
    September 29, 2014
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01709812
    Brief Title
    Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS
    Acronym
    STAY
    Official Title
    A 6 Months, Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With Relapsing-remitting Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    July 2013 (Anticipated)
    Study Completion Date
    July 2013 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in RRMS patients to assess the impact of an individualized patient support program (PSP) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing-remitting Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 standard care
    Arm Type
    Other
    Arm Description
    standard care
    Arm Title
    2 individualized PSP
    Arm Type
    Experimental
    Arm Description
    individualized patient support program
    Intervention Type
    Other
    Intervention Name(s)
    individualized patient support program
    Intervention Description
    individualized patient support with compliance supporting tools
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Primary Outcome Measure Information:
    Title
    change in treatment satisfaction (TSQM-9) from baseline to month 6
    Description
    To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    change in Modified Morisky Scale score from baseline to month 6
    Description
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    Time Frame
    6 months
    Title
    quantification of therapy adherence (pill-count) over 6 months
    Description
    To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill-count in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    Time Frame
    6 months
    Title
    change in mFIS score from baseline to month 6
    Description
    To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    Time Frame
    6 months
    Title
    change in BDI from baseline to month 6
    Description
    To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients eligible for inclusion in this trial have to fulfill all of the following criteria: Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. Male or female subjects aged 18 - 65 years. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1). Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: Patients, who are registered in any patient support program (e.g. Extracare) Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum) Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details). Simultaneous participation in another clinical trial. Patients, who have already been randomized into this trial earlier must not be included a second time. Study personnel or first degree relatives of investigator(s) must not be included in the study.
    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

    Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS

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