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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Relapsing-remitting Multiple Sclerosis
• Intervention / Treatment: Other: Standard care; Other: individualized patient support program

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Estimate): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: CFTY720DDE19