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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578330
• Other study ID #: CFTY720DTR01
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2012
• Last updated: March 1, 2016
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with RRMS as described in 2005 Mc Donald criteria

2. Provided written informed consent prior to any intervention

3. Female or male patients aged 18-65 years

4. Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum of one year at and at adequate dose and with high disease activity

(Unresponsive patients: patients with no changes in relapses, increased relapses, severer relapses with one-year treatment or those who had had at least one relapse during the past one year under previous treatments and one or multiple contrast enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)

5. EDSS score below 5.5 at baseline

Exclusion Criteria:

• Treatment-naive RRMS patients 2. History of a chronic disease of the immune system other than MS or known immunodeficiency 3. Past or current malignancy 4. Diabetic patients with mild or severe, non-proliferative or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8% 5. Evidence of macular edema (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at screening.) 6. Evidence of uveitis 7. EDSS score > 5.5 at baseline 8. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests 9. No history of varicella and negative varicella-zoster virus IhH antibody test at screening (such patients may be included after being administered VZV vaccine, at least 1 month following vaccination.) 10. Patients who received any live or live attenuated vaccine during the last one month (including varicella-zoster virus or measles) 11. Patients who received total lymphoid irradiation or bone marrow transplantation 12. Patient who received any of the treatment below:

1. Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month

2. Immunosuppressive medications such as azathioprine or methotrexate etc.

3. Immunoglobulin treatment during the last 3 months

4. Cladribine, cyclophosphamide, mitoxantrone, natalizumab at any time 13. Patients with any of the following cardiovascular conditions: Resting heart rate < 45 bpm/min Cardiac failure at time of screening (Class III according to NYHA classification) or any severe cardiac as determined by the physician Myocardial infarction during the last 6 months History of Mobitz Type II grade 2 AV block Past or current grade 3 AV block Confirmed history of sick sinus syndrome or sino-atrial heart block arrhythmia requiring current treatment with Class Ia drugs (ajmaline, disopyramid, procainamide, quinidine) hypertension uncontrolled with medication 14. Patients with any of the pulmonary conditions below severe respiratory disease or pulmonary fibrosis Uncontrolled asthma 15. Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation and should be confirmed by a positive hCG laboratory test (> 5 mIU/ml).

16. Patients with any of the hepatic conditions below: Alcohol abuse, chronic hepatic or biliary disease, severe hepatic impairment (Child- Pugh class C) Total bilirubin above the upper limit of normal provided that it is not associated with Gilbert's syndrome Conjugated bilirubin above the upper limit of normal Alkaline phosphate (AP) 1.5 times above the upper limit of normal AST(SGOT), ALT (SGPT) 2 times above the upper limit of normal, gamma-glutamyl-transferase (GGT) 3 times above the upper limit of normal

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing-Remitting

Intervention

Drug:
• Fingolimod
Fingolimod 0.5mg orally once a day without food.

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Atakum / Samsun
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Mecidiyekoy/Istanbul
Turkey	Novartis Investigative Site	Trabzon
Turkey	Novartis Investigative Site	Uskudar / Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication	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.	Basleine and month 1	Yes
Primary	Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication	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.	Baseline and month 6	Yes
Primary	Change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication	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.	Baseline and month 12	Yes
Secondary	Change in patient-reported health-related quality-of-life with Fingolimod (	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).	months 0, 1, 6 and 12	Yes
Secondary	Tolerability evaluations will be via ophthalmologic examination, first Dose Monitoring, ECG, Hematology, Serology and Blood chemistry		Throughout the study	Yes