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

Phase 4

Completed

• Conditions: Relapsing-Remitting; Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT01578330
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Study Start: 2012-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-04
• Results First Submitted: 2016-04-29
• Results First Submitted QC: 2016-04-29
• Last Update Submitted: 2016-04-29
• Results First Posted: 2016-06-07
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod, FTY720	Fingolimod	Patients received fingolimod 0.5 mg oral capsules daily with or without food.

Primary Outcome Measures

Name	Time	Method
Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)	Baseline and month 12	The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).	Month 12	The SF-36v2 is a validated 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). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Uskudar / Istanbul, Turkey