| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Relapsing Remitting Multiple Sclerosis |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10063399 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective of the study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9). |
|
| E.2.2 | Secondary objectives of the trial |
| To evaluate in patients who have been previously treated for RRMS:safety and tolerability immediately after a change in DMT and during 6 months of treatment with fingolimod vs.DMT standard of care in patients who have been previously treated for RRMS; the change in patient-reported ADL with fingolimod vs.DMT standard of care, using the PRIMUS-Activities;the change in patient-reported fatigue with fingolimod vs.DMT standard of care, using the Fatigue Severity Scale (FSS);changes in patient–reported effectiveness and convenience subscales with fingolimod vs.DMT standard of care, using the TSQM-9;the change in patient-reported depression with fingolimod vs. DMT standard of care, using the BDI-FS;the change in patient-reported health-related quality-of-life with fingolimod vs.DMT standard of care, using the SF-36 v1.To measure the physician-reported CGI-I with fingolimod vs DMT standard of care in patients who have been previously treated for RRMS |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| 1.Written informed consent must be obtained before any assessment is performed 2.Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2) 3.Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator 4.Male or female patients aged 18-65 years 5.An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive 6.Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit 7.Na�ve to treatment with fingolimod. |
|
| E.4 | Principal exclusion criteria |
1.A manifestation of MS other than those defined in the inclusion criteria 2.A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome 3.History of malignancy of any organ system (other than localized basal cell carcinoma of
the skin), treated or untreated, within the past 5 years, regardless of whether there is
evidence of local recurrence or metastases 4. Patients with uncontrolled diabetes mellitus (HbA1c > 7%) 5. Diagnosis of macular edema during Screening Phase 6. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests 7.Patients who test negative for varicella-zoster virus IgG antibodies at screening. If these patients elect to be vaccinated, they may return to be rescreened at least one month after
the vaccination 8.Patients who have received any live or live attenuated vaccines (including for varicellazoster virus or measles) within 2 months prior to baseline 9. Patients who have received total lymphoid irradiation or bone marrow transplantation 10.Patients who have been treated with:corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to
randomization, immunosuppressive medications such as azathioprine or methotrexate within 3
months prior to baseline,immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to baseline, cladribine, cyclophosphamide or mitoxantrone at any time 11. Any medically unstable condition, as assessed by the investigator 12. Any of the following cardiovascular conditions and/or findings in the screening ECG: history of cardiac arrest, myocardial infarction within the past 6 months prior to enrollment or with current
unstable ischemic heart disease,known history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon, cardiac failure at time of Screening or any severe cardiac disease as determined by the investigator, history or presence of a Mobitz 2 second degree AV block or a third degree AV block or an increased QTc interval >450 ms in males and >470 ms in females corrected using Bazett’s formula, patients receiving Class Ia and III
antiarrhythmic drugs,resting pulse rate <45 bpm prior to baseline, proven history of sick sinus syndrome or sino-atrial heart block hypertension, not controlled by prescribed medications 13.Any of the following pulmonary conditions: pulmonary fibrosis,active tuberculosis 14.Any of the following hepatic conditions: chronic liver or biliary disease, total bilirubin greater than 2 times the upper limit of the normal range, unless in context of Gilbert’s syndrome, conjugated bilirubin greater than 2 times the upper limit of the normal range, AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range,alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal rang, gamma-glytamyl-transferase (GGT) greater than 3 times the upper limit of the normal range 15. Abnormal laboratory values at screening 16. Patients with some neurologic/psychiatric disorders 17.Participation in any clinical research study within 6 months prior to baseline 18. History of hypersensitivity to the study drug or to drugs of similar chemical classes 19. Pregnant or nursing (lactating) women, confirmed by a positive hCG laboratory test (> 5 mIU/ml). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary objective of the study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 35 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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