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

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Other: individualized patient support program; Other: Standard care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709812

CFTY720DDE19

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1 standard care

Other group

Description:

standard care

Treatment:

Other: Standard care

2 individualized PSP

Experimental group

Description:

individualized patient support program

Treatment:

Other: individualized patient support program