A Phase 4 interventional study of Fingolimod in Multiple Sclerosis and Relapsing-Remitting, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Supportive care
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
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:
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 received fingolimod 0.5 mg oral capsules daily with or without food.
Drug: Fingolimod
Fingolimod 0.5mg orally once a day without food.
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.
Time frame: Baseline and month 12
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
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.
Time frame: Month 1
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
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.
Time frame: Month 6
Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).
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.
Time frame: Month 12
| Milestone | Fingolimod, FTY720 |
|---|---|
| Started | 42 |
| Per protocol population | 35 |
| Completed | 35 |
| Not completed | 7 |
| Withdrew: Adverse event | 2 |
| Withdrew: Protocol violation | 5 |
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.
| Scores on a scale | Fingolimod, FTY720 |
|---|---|
| Baseline (n=34) | 32.0 ± 9.9 |
| Month 12 (n=32) | 44.7 ± 9.9 |
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.
| score on scale | Fingolimod, FTY720 |
|---|---|
| Physical Function | 59.7 ± 30.9 |
| Physical Role | 53.6 ± 43.8 |
| Pain | 61.7 ± 23.7 |
| General Health | 47.8 ± 20.5 |
| Vitality | 28.9 ± 23.1 |
| Social Function | 61.8 ± 26.4 |
| Emotional Role | 48.4 ± 43.0 |
| Mental Health | 31.5 ± 17.0 |
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.
| score on scale | Fingolimod, FTY720 |
|---|---|
| Physical Function (n=33) | 57.9 ± 31.1 |
| Physical Role (n=34) | 47.8 ± 46.0 |
| Pain (n=34) | 62.6 ± 24.8 |
| General Health (n=33) | 48.5 ± 20.3 |
| Vitality (n=34) | 35.2 ± 22.9 |
| Social Function (n=34) | 60.6 ± 29.9 |
| Emotional Role (n=34) | 54.8 ± 43.3 |
| Mental Health (n=34) | 36.5 ± 20.3 |
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.
| score on scale | Fingolimod, FTY720 |
|---|---|
| Physical Function (n=31) | 59.5 ± 34.3 |
| Physical Role (n=32) | 46.9 ± 44.7 |
| Pain (n=32) | 65.9 ± 23.3 |
| General Health (n=31) | 50.8 ± 21.9 |
| Vitality (n=32) | 33.1 ± 20.0 |
| Social Function (n=32) | 65.8 ± 29.1 |
| Emotional Role (n=31) | 52.7 ± 46.2 |
| Mental Health (n=32) | 36.3 ± 20.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod, FTY720 | — | 4/42 (9.5%) | 24/42 (57.1%) |
| Event | Fingolimod, FTY720 |
|---|---|
| Multiple Sclerosis aggravatedImmune system disorders | 1/42 |
| FractureInjury, poisoning and procedural complications | 1/42 |
| Medication taken before pregnancyInjury, poisoning and procedural complications | 1/42 |
| Middle ear infection surgerySurgical and medical procedures | 1/42 |
| Event | Fingolimod, FTY720 |
|---|---|
| Urinary infectionRenal and urinary disorders | 9/42 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 8/42 |
| LymphopeniaBlood and lymphatic system disorders | 7/42 |
| Increase of hepatic enzymesHepatobiliary disorders | 5/42 |
| Multiple Sclerosis AggravatedImmune system disorders | 4/42 |
| HeadacheNervous system disorders | 4/42 |
| HyperlipidemiaMetabolism and nutrition disorders | 4/42 |
| Tooth abscessInfections and infestations | 3/42 |
| NauseaGastrointestinal disorders | 3/42 |
| IncontinenceRenal and urinary disorders | 3/42 |
| Age, Continuous(Years) | Fingolimod, FTY720 |
|---|---|
| Mean | 35.7 ± 9.4 |
| Sex: Female, Male(Participants) | Fingolimod, FTY720 |
|---|---|
| Female | 16 |
| Male | 26 |
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