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

NCT01709812 | Withdrawn Phase 4

• 1 other identifier: CFTY720DDE19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change in Modified Morisky Scale score from baseline to month 6

  6 months

• quantification of therapy adherence (pill-count) over 6 months

  6 months

• change in mFIS score from baseline to month 6

  6 months

• change in BDI from baseline to month 6

  6 months

Study Arms (2)

1 standard care

OTHER

standard care

Other: Standard care

2 individualized PSP

EXPERIMENTAL

individualized patient support program

Other: individualized patient support program

Interventions

individualized patient support program OTHER

individualized patient support with compliance supporting tools

2 individualized PSP

Standard care OTHER

1 standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: July 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 30, 2014

Record last verified: 2014-09