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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01709812
First received: October 16, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
Other: individualized patient support program
Other: Standard care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • change in treatment satisfaction (TSQM-9) from baseline to month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: July 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 standard care
standard care
Other: Standard care
Experimental: 2 individualized PSP
individualized patient support program
Other: individualized patient support program
individualized patient support with compliance supporting tools

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709812

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01709812     History of Changes
Other Study ID Numbers: CFTY720DDE19
Study First Received: October 16, 2012
Last Updated: September 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014