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

NCT01578330 | Completed Phase 4 Results

• 1 other identifier: CFTY720DTR01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 11

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.

Conditions

Multiple Sclerosis; Relapsing-Remitting

Keywords

Relapsing remitting multiple sclerosis; Fingolimod; FTY720

Outcome Measures

Primary Outcomes (1)

• Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)

  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.

  Baseline and month 12

Secondary Outcomes (3)

• Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).

  Month 1

• Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).

  Month 6

• Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).

  Month 12

Study Arms (1)

Fingolimod, FTY720

EXPERIMENTAL

Patients received fingolimod 0.5 mg oral capsules daily with or without food.

Drug: Fingolimod

Interventions

Fingolimod DRUG

Fingolimod 0.5mg orally once a day without food.

Fingolimod, FTY720

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with RRMS as described in 2005 Mc Donald criteria
• Provided written informed consent prior to any intervention
• Female or male patients aged 18-65 years
• 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)
• EDSS score below 5.5 at baseline

You may not qualify if:

• 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:
• Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month
• Immunosuppressive medications such as azathioprine or methotrexate etc.
• Immunoglobulin treatment during the last 3 months
• 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).
• \. 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06500, Turkey (Türkiye)

Location

Novartis Investigative Site

Bursa, Turkey, 16059, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey, 35040, Turkey (Türkiye)

Location

Novartis Investigative Site

Altunizade, 34662, Turkey (Türkiye)

Location

Novartis Investigative Site

Atakum / Samsun, 55139, Turkey (Türkiye)

Location

Novartis Investigative Site

Fatih / Istanbul, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

Novartis Investigative Site

Mecidiyekoy/Istanbul, 34394, Turkey (Türkiye)

Location

Novartis Investigative Site

Trabzon, 61080, Turkey (Türkiye)

Location

Novartis Investigative Site

Uskudar / Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: April 16, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 7, 2016
• Results First Posted: June 7, 2016

Record last verified: 2016-04

Locations

TU (11)