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.

ovartis Pharma Services AG0 sites4,125 target enrollmentFebruary 15, 2011

ConditionsRelapsing multiple sclerosis MedDRA version: 13.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsing multiple sclerosis
Sponsor: ovartis Pharma Services AG
Enrollment: 4125
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 15, 2011

End Date

October 19, 2018

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility 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 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

Exclusion Criteria

•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.