<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709812</url>
  </required_header>
  <id_info>
    <org_study_id>CFTY720DDE19</org_study_id>
    <nct_id>NCT01709812</nct_id>
  </id_info>
  <brief_title>Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS</brief_title>
  <acronym>STAY</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study&#xD;
      in RRMS patients to assess the impact of an individualized patient support program (PSP) on&#xD;
      treatment satisfaction and to evaluate whether this individualized support improves&#xD;
      satisfaction and with it adherence to medication compared to standard care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in treatment satisfaction (TSQM-9) from baseline to month 6</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Modified Morisky Scale score from baseline to month 6</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quantification of therapy adherence (pill-count) over 6 months</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in mFIS score from baseline to month 6</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in BDI from baseline to month 6</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Relapsing-remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>1 standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 individualized PSP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>individualized patient support program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>individualized patient support program</intervention_name>
    <description>individualized patient support with compliance supporting tools</description>
    <arm_group_label>2 individualized PSP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <arm_group_label>1 standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients eligible for inclusion in this trial have to fulfill all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Written informed consent from patients capable of giving or withholding full informed&#xD;
             consent must be obtained before any assessment is performed.&#xD;
&#xD;
          2. Male or female subjects aged 18 - 65 years.&#xD;
&#xD;
          3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.&#xD;
&#xD;
          4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.&#xD;
&#xD;
          5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at&#xD;
             Study Visit 1 (Day 1).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients fulfilling any of the following criteria are not eligible for inclusion in this&#xD;
        study:&#xD;
&#xD;
          1. Patients, who are registered in any patient support program (e.g. Extracare)&#xD;
&#xD;
          2. Patients with any relevant medically unstable condition, as assessed by the primary&#xD;
             treating physician at each site.&#xD;
&#xD;
          3. Any severe disability or clinical impairment that can prevent the patient to meet all&#xD;
             study requirements at the investigator's discretion&#xD;
&#xD;
          4. History of malignancy of any organ system, treated or untreated, within the past 5&#xD;
             years whether or not there is evidence of local recurrence or metastases, with the&#xD;
             exception of localized basal cell carcinoma of the skin&#xD;
&#xD;
          5. Patients who have received an investigational drug (excluding Fingolimod) or therapy&#xD;
             within 90 days or 5 half-lives prior to screening, whichever is longer.&#xD;
&#xD;
          6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive pregnancy test (serum)&#xD;
&#xD;
          7. Women of childbearing potential unwilling to use contraceptive precautions throughout&#xD;
             the study (see section 7.13.6 for details).&#xD;
&#xD;
          8. Simultaneous participation in another clinical trial.&#xD;
&#xD;
        Patients, who have already been randomized into this trial earlier must not be included a&#xD;
        second time.&#xD;
&#xD;
        Study personnel or first degree relatives of investigator(s) must not be included in the&#xD;
        study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709812
org study id: CFTY720DDE19
nct id: NCT01709812
lead sponsor: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in treatment satisfaction (TSQM-9) from baseline to month 6
time frame: 6 months
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.
measure: change in Modified Morisky Scale score from baseline to month 6
time frame: 6 months
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.
measure: quantification of therapy adherence (pill-count) over 6 months
time frame: 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.
measure: change in mFIS score from baseline to month 6
time frame: 6 months
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.
measure: change in BDI from baseline to month 6
time frame: 6 months
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.
arm group label: 1 standard care
arm group type: Other
description: standard care
arm group label: 2 individualized PSP
arm group type: Experimental
description: individualized patient support program
intervention type: Other
intervention name: individualized patient support program
description: individualized patient support with compliance supporting tools
arm group label: 2 individualized PSP
intervention type: Other
intervention name: Standard care
arm group label: 1 standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis