Effect of an Individualized Patient Support Program on Treatment Satis
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
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- individualized patient support program
- Standard care
What it measured
Main measures
change in treatment satisfaction (TSQM-9) from baseline to month 6
6 months
Quality of life (reported by participants)
Other measures (4)
change in Modified Morisky Scale score from baseline to month 6
6 months
Quality of life (reported by participants)quantification of therapy adherence (pill-count) over 6 months
6 months
Quality of life (reported by participants)change in mFIS score from baseline to month 6
6 months
Fatiguechange in BDI from baseline to month 6
6 months
Mood and sleep
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6.5
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jul 2013
Main results due
Jul 2013
Finished
Jul 2013