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Completed

NCT Number: NCT02335892

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

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Truro, Cornwall, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

There are no exclusion criteria for this study.

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Treatment and study plan

Primary outcomes

  1. Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)

    Time frame: 12 months

Secondary outcomes

  1. MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them

    Time frame: 12 months

  2. Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment

    Time frame: 12 months

  3. Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya

    Time frame: 12 months

  4. Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29

    Time frame: 12 months

  5. Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)

Acronym: PROFILE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2015
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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