Phase 4
Completed N=42
A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
Multiple Sclerosis · Relapsing-Remitting
Source: ClinicalTrials.gov NCT01578330 ↗
Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Jun 2016
Primary outcomePrimary: Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9) — 32.0; 44.7 Scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9) |
32.0; 44.7 | — |
| SECONDARY Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). |
59.5; 46.9; 65.9; 50.8; 33.1; 65.8 | — |
| SECONDARY Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). |
59.5; 46.9; 65.9; 50.8; 33.1; 65.8 | — |
| SECONDARY Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). |
59.5; 46.9; 65.9; 50.8; 33.1; 65.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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:
- 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 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
Data sourced from ClinicalTrials.gov (NCT01578330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.