A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.
- Conditions
- Relapsing multiple sclerosisMedDRA version: 13.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2010-020515-37-GR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5000
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.
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) no
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 of a previous fingolimod study.
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, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods, at least 1 of which must be a primary form.
4. Chronic disease of the immune system other than MS which may require immunosuppressive treatment.
5. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
6. 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.
7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
8. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study.
9. 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.
10. Any of the following cardiovascular conditions that have developed during the previous fingolimod study.
For a detailed descrition of all exclusion criteria, please see section 4.2 of the enclosed protocol.
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 relapsing forms of MS.;Secondary Objective: This study will also evaluate long-term efficacy in patients with relapsing forms of MS who are treated with fingolimod 0.5 mg/day.;Primary end point(s): Adverse events (AEs), laboratory, vital signs, ECG, and ophthalmology assessments and skin assessment data will be used to evaluate the primary objective.
- Secondary Outcome Measures
Name Time Method