A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01578330
First received: March 16, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The study will assess the patients' satisfaction of treatment after 12 months treatment with fingolimod It also will assess the tolerability profile of fingolimod in a small population.


Condition Intervention Phase
Multiple Sclerosis
Relapsing-Remitting
Drug: Fingolimod
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- Fine

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication [ Time Frame: Basleine and month 1 ] [ Designated as safety issue: Yes ]
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to psychometrically evaluate the patients' satisfaction with Fingolimod. The TSQM-9 is a sound and valid measure of the major dimensions of patients' satisfaction with medication and also a good predictor of adherence across different types of medication and patient population.

  • Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: Yes ]
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to psychometrically evaluate the patients' satisfaction with Fingolimod. The TSQM-9 is a sound and valid measure of the major dimensions of patients' satisfaction with medication and also a good predictor of adherence across different types of medication and patient population.

  • Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: Yes ]
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to psychometrically evaluate the patients' satisfaction with Fingolimod. The TSQM-9 is a sound and valid measure of the major dimensions of patients' satisfaction with medication and also a good predictor of adherence across different types of medication and patient population.


Secondary Outcome Measures:
  • Change in patient-reported health-related quality-of-life with Fingolimod ( [ Time Frame: months 0, 1, 6 and 12 ] [ Designated as safety issue: Yes ]
    The SF-36 is a validated and widely used health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

  • Tolerability evaluations will be via ophthalmologic examination, first Dose Monitoring, ECG, Hematology, Serology and Blood chemistry [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod, FTY720 Drug: Fingolimod
All the patients will get oral fingolimod once a day.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria
  • Patients who are candidates for RRMS therapy change from Previous Disease
  • Patients with high disease activity despite treatment with a beta-interferon

Exclusion Criteria:

- Diagnosis of macular edema (patients with a history of macular edema will be allowed to enter the program provided that they do not have macular edema at the first visit).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578330

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Turkey
Novartis Investigative Site Recruiting
Altunizade, Turkey, 34662
Novartis Investigative Site Recruiting
Ankara, Turkey, 06500
Novartis Investigative Site Not yet recruiting
Ankara, Turkey, 06100
Novartis Investigative Site Recruiting
Atakum / Samsun, Turkey, 55139
Novartis Investigative Site Recruiting
Bursa, Turkey, 16059
Novartis Investigative Site Not yet recruiting
Haseki / Istanbul, Turkey, 34096
Novartis Investigative Site Not yet recruiting
Istanbul, Turkey, 34093
Novartis Investigative Site Not yet recruiting
Istanbul, Turkey, 34147
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34303
Novartis Investigative Site Not yet recruiting
Istanbul, Turkey, 34722
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Kocaeli, Turkey, 41380
Novartis Investigative Site Not yet recruiting
Mecidiyekoy/Istanbul, Turkey, 34394
Novartis Investigative Site Recruiting
Trabzon, Turkey, 61080
Novartis Investigative Site Recruiting
Uskudar / Istanbul, Turkey, 34668
Novartis Investigative Site Not yet recruiting
Yenisehir / Izmir, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01578330     History of Changes
Other Study ID Numbers: CFTY720DTR01
Study First Received: March 16, 2012
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
Turkey: Ministry of Health

Keywords provided by Novartis:
Relapsing remitting multiple sclerosis
Fingolimod
FTY720

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014