Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 March 2013 |
Main ID: |
EUCTR2012-002637-11-DE |
Date of registration:
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09/10/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
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Scientific title:
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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 (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAY |
Date of first enrolment:
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15/10/2012 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002637-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: individualized patient support programm
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Project Leader
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Address:
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Roonstr. 25
90429
Nürnberg
Germany |
Telephone:
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004991127313187 |
Email:
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francisca.blumhagen@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Name:
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Project Leader
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Address:
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Roonstr. 25
90429
Nürnberg
Germany |
Telephone:
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004991127313187 |
Email:
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francisca.blumhagen@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion 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).
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 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 7.9.5 for details).
8. Simultaneous participation in another clinical trial.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment statisfaction in patients with relapsing remitting Multiple Sclerosis MedDRA version: 15.0
Level: PT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Pharmaceutical Form: Capsule, hard CAS Number: 162359-56-0 Current Sponsor code: FTY720 Other descriptive name: Fingolimod Hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5-
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Primary Outcome(s)
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Main Objective: 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.
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Primary end point(s): 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.
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Secondary Objective: 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. 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. 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. 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.
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Timepoint(s) of evaluation of this end point: after 6 month
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Secondary Outcome(s)
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Secondary end point(s): 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.
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.
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.
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.
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Timepoint(s) of evaluation of this end point: after 6 month
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Secondary ID(s)
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CFTY720DDE19
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Source(s) of Monetary Support
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Novartis Pharma GmbH
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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