ong-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis
- Conditions
- multiple sclerosisMedDRA version: 18.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-020515-37-PT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 4125
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 trials with fingolimod, including phase II/III patients who have already completed CFTY720D2399,CFTY720D2309/E1 or one of the phase II/III core or extension studies.
3. Patients who participated in any designated global fingolimod MS trial other than phase II/III (e.g. CFTY720D2316, CFTY720D2320, etc.) and are less than 180 days beyond the time of local approval and general reimbursement.
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
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).
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 tub
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study is designed to evaluate the long-term safety and tolerability of fingolimod 0.5 mg/day in patients with MS.;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;Primary end point(s): Long term safety will be asssessed 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.;<br> 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)<br> <br> Hematology laboratory assessment every 6 months, blood chemistry yearly, eye examination yearly after the first year, urine pregnancy test at the 6 months visit<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): MRI, MS Relapse, EDSS scores, MSFC scores<br> ;<br> 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)<br> MRIs at EOS visit<br> <br>