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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01578330
• Date of registration: 16/03/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
• Scientific 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
• Date of first enrolment: October 2012
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01578330
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Relapsing-Remitting

Intervention(s)

Drug: Fingolimod

Primary Outcome(s)

Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9) [Time Frame: Baseline and month 12]

Secondary Outcome(s)

Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). [Time Frame: Month 12]

Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). [Time Frame: Month 6]

Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). [Time Frame: Month 1]

Secondary ID(s)

CFTY720DTR01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/06/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01578330