Relapsing-remitting Multiple SclerosisPhase 4STAYNCT01709812
Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS
A Phase 4 study testing individualized patient support program in people with Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- individualized patient support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this trial have to fulfill all of the following criteria:
- 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).
Who cannot join
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- 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.
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- 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.
About this study
Official title: 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
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
- Being tested
- individualized patient support program, Standard care
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized patient support programOther
individualized patient support with compliance supporting tools
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| 1 standard care | Other | standard care Receives: Other: Standard care |
| 2 individualized PSP | Experimental | individualized patient support program Receives: Other: individualized patient support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
change in Modified Morisky Scale score from baseline to month 6
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.
Measured: 6 months
quantification of therapy adherence (pill-count) 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.
Measured: 6 months
change in mFIS score from baseline to month 6
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.
Measured: 6 months
change in BDI from baseline to month 6
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJul 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709812
- Sponsor's protocol ID
- CFTY720DDE19
- Acronym
- STAY
- Status last verified
- Sep 2014
- First submitted
- 16 Oct 2012
- Last updated
- 30 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01709812
- Acronym / sponsor ID
- STAY / CFTY720DDE19
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 standard care | Other | Other: Standard carestandard care |
| 2 individualized PSP | Experimental | Other: individualized patient support programindividualized patient support program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients eligible for inclusion in this trial have to fulfill all of the following criteria:
- 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.
Key exclusion criteria (11 listed)
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized patient support programindividualized patient support with compliance supporting tools | Other | 2 individualized PSP |
| Standard care | Other | 1 standard care |
Primary outcome
change in treatment satisfaction (TSQM-9) from baseline to month 6
Time frame: 6 months
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.
4 secondary outcomes
change in Modified Morisky Scale score from baseline to month 6
Time frame: 6 months
quantification of therapy adherence (pill-count) over 6 months
Time frame: 6 months
change in mFIS score from baseline to month 6
Time frame: 6 months
change in BDI from baseline to month 6
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing individualized patient support program in people with Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in treatment satisfaction (TSQM-9) from baseline to month 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.