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

NCT ID: NCT01709812

Last Updated: 2014-09-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 standard care

standard care

Group Type: OTHER

Standard care

Intervention Type: OTHER

2 individualized PSP

individualized patient support program

Group Type: EXPERIMENTAL

individualized patient support program

Intervention Type: OTHER

individualized patient support with compliance supporting tools

Interventions

individualized patient support program

individualized patient support with compliance supporting tools

Intervention Type: OTHER

Standard care

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CFTY720DDE19

Identifier Type: -

Identifier Source: org_study_id