Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

Inclusion Criteria:

• Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria

• Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5

Exclusion Criteria:

• Patients with a manifestation of MS other than relapsing remitting MS

• Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome

• History or presence of malignancy in the last 5 years

• Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients

• Diagnosis of macular edema during Screening Phase

• Patients with active systemic bacterial, viral or fungal infections

• Negative for varicella-zoster virus IgG antibodies at Screening

• Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time

• History of cardiovascular disorder

• Women of child-baring potential and inadequate contraception

Other protocol-defined inclusion/exclusion criteria may apply