PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod

NCT ID: NCT02335892

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-11

Study Completion Date

2017-02-01

Brief Summary

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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

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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

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Relapsing Remitting Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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 -

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Truro, Cornwall, United Kingdom

Site Status

Novartis Investigative Site

Swansea, England, United Kingdom

Site Status

Novartis Investigative Site

Romford, Essex, United Kingdom

Site Status

Novartis Investigative Site

Basingstoke, Hampshire, United Kingdom

Site Status

Novartis Investigative Site

Edinburgh, , United Kingdom

Site Status

Novartis Investigative Site

Glasgow, , United Kingdom

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Novartis Investigative Site

Liverpool, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Norwich, , United Kingdom

Site Status

Novartis Investigative Site

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CFTY720DGB04

Identifier Type: -

Identifier Source: org_study_id

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