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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01709812
• Other study ID #: CFTY720DDE19
• Status: Withdrawn
• Phase: Phase 4
• First received: October 16, 2012
• Last updated: September 29, 2014
• Start date: July 2013
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• individualized patient support program
individualized patient support with compliance supporting tools
• Standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No