multiple sclerosis MedDRA version: 19.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descri
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Patients who have completed designated ongoing or planned Novartis global clinical trials with fingolimod and are unable to obtain fingolimod outside a clinical trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Premature permanent discontinuation from any fingolimod study due to: a. An adverse event or serious adverse event or laboratory abnormality. b. Conditions leading to permanent study drug discontinuation. Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re-enrolled. 2. Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml). Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re-enrolled. 3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using highly effective contraception during the study and for 2 months after stopping treatment. ‘Highly effective contraception’defined as contraception which results in less than 1% unwanted pregnancies when used properly according to the label. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. 4. Chronic disease of the immune system other than MS which may require immunosuppressive treatment. 5. Severe active infection or active chronic infection. 6. Previous treatment with cladribine, cyclophosphamide or mitoxantrone. 7. Treatment with monoclonal antibodies (including Natalizumab) in the past 3 months. 8. Uncontrolled diabetes (HbA1c>9%). 9. Macular edema at Baseline. 10. Any medically unstable condition that may interfere with the patient’s ability to cooperate and comply with the study procedures, as assessed by the treating physician. 11. Any of the following cardiovascular conditions: a. myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease; b. cardiac failure at time of Screening (Class III & IV, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; c. patients receiving current treatment with Class Ia and III antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide); d. second-degree AV block Type II or third-degree AV block or corrected QTc inverval >450 msec in males or 470 msec in females; e. sick sinus syndrome or sino-atrial heart block; f. uncontrolled hypertension despite prescribed medications. 12. Any of the following pulmonary conditions during the previous fingolimod study or observed at enrollment visit: a. severe respiratory disease or pulmonary fibrosis; b. active tuberculosis; c. in patients enrolling from studies with regular spirometry: reduction of FEV1, FVC and/or DLCO below 60% of core study baseline values or if FEV1, FVC and/or DLCO at extension study baseline is the second of two consecutive pulmonary function tests with values <8
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to evaluate the long-term safety and tolerability of fingolimod 0.5 mg/day in patients with MS for the duration of the study.;Secondary Objective: This study will also evaluate long-term efficacy of fingolimod 0.5 mg/day in patients with MS, as measured by disability progression, brain volume (atrophy), T1- (non-enhanced) and T2-weighted lesion volume and MS relapse occurrence in Study Part One.;Primary end point(s): For Part 1 : Long-term safety will be assessed based on adverse events (AEs), Physical/neurological examination, laboratory evaluation, eye exam, ECG and vital signs, as well as other investigations performed when clinically indicated. For Part 2 : During Study Part Two, only adverse events, first dose monitoring, vital signs, Ophthalmological exam/OCT, physical/neurological examination and relapse are collected. The follow-up safety data after discontinuation of the study treatment in Study Part One or Study Part Two will also be summarized where appropriate.;Timepoint(s) of evaluation of this end point: For Part 1 : Visits every 3 months through Month 12 (v5); Visits every 6 months beginning after Month 12 at Month 18 (v6). Biomarkers to be collected at EOS in a subset of patients meeting pre-specified criteria, eye examination yearly after the first year, urine pregnancy test at the 6 months visit For Part 2 : Visits at Month 1, Month 3, Month 6*, Month 12*, and every 6 months until Study Completion. * No eye exam. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MRI, MS Relapse, EDSS scores, MSFC scores in Study Part One only ;Timepoint(s) of evaluation of this end point: Visits every 3 months through Month 12 (v5); Visits every 6 months beginning after Month 12 at Month 18 (v6) MRIs at EOS visit | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Jordan, Korea, Republic of, Malaysia, Netherlands, Norway, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactMedical Information Service
Novartis Finland Oy
Outcome results
None listed