Relapsing Remitting Multiple SclerosisPROFILENCT02335892
PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod
An observational study of Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 14 sites in United Kingdom.
Trial summary
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 114 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 11 Nov 2014to 1 Feb 2017
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod
Who may be able to join
- Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age -
Who cannot join
- There are no exclusion criteria for this study.
- -
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Edinburgh, EH16 4SA
Novartis Investigative Site
Glasgow, G51 4TF
Novartis Investigative Site
Leicester, LE5 4PW
Novartis Investigative Site
Liverpool, L9 7LT
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SW17 0QT
Novartis Investigative Site
London, W6 8RF
Novartis Investigative Site
London, WC1N 3BG
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Nottingham, NG5 1PB
Novartis Investigative Site
Romford, Essex, RM7 0AG
Novartis Investigative Site
Swansea, England, SA6 6NL
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ
About this study
Official title: Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.
Read the detailed description
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)
Measured: 12 months
Secondary outcomes (5)
MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them
Measured: 12 months
Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment
Measured: 12 months
Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya
Measured: 12 months
Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29
Measured: 12 months
Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start11 Nov 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 114 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
- NCT02335892
- Sponsor's protocol ID
- CFTY720DGB04
- Acronym
- PROFILE
- Status last verified
- Mar 2019
- First submitted
- 2 Dec 2014
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)
- ClinicalTrials.gov ID
- NCT02335892
- Acronym / sponsor ID
- PROFILE / CFTY720DGB04
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 12 Jan 2015 (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.
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.
Detailed description
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod
Key inclusion criteria (1 listed)
- Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age -
Key exclusion criteria (2 listed)
- There are no exclusion criteria for this study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)
Time frame: 12 months
5 secondary outcomes
MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them
Time frame: 12 months
Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment
Time frame: 12 months
Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya
Time frame: 12 months
Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29
Time frame: 12 months
Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 14 sites in United Kingdom.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains) (time frame: 12 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 1 Apr 2019.