A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01578330
First received: March 16, 2012
Last updated: February 18, 2013
Last verified: February 2013
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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: | July 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (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 | Not yet recruiting |
| Altunizade, Turkey, 34662 | |
| Novartis Investigative Site | Recruiting |
| Ankara, Turkey, 06500 | |
| Novartis Investigative Site | Not yet recruiting |
| Ankara, Turkey, 06100 | |
| Novartis Investigative Site | Not yet recruiting |
| Atakum / Samsun, Turkey, 55139 | |
| Novartis Investigative Site | Not yet 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 | Not yet recruiting |
| Istanbul, Turkey, 34303 | |
| Novartis Investigative Site | Not yet recruiting |
| Istanbul, Turkey, 34722 | |
| Novartis Investigative Site | Not yet recruiting |
| Izmir, Turkey, 35040 | |
| Novartis Investigative Site | Not yet recruiting |
| Kocaeli, Turkey, 41380 | |
| Novartis Investigative Site | Not yet recruiting |
| Mecidiyekoy/Istanbul, Turkey, 34394 | |
| Novartis Investigative Site | Not yet recruiting |
| Trabzon, Turkey, 61080 | |
| Novartis Investigative Site | Not yet 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: | February 18, 2013 |
| 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 May 16, 2013