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

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01310166

2010-022066-28 (EudraCT Number)

CFTY720DDE01

Details and patient eligibility

About

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.

Enrollment: 447 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

447 participants in 1 patient group

Fingolimod

Experimental group

Treatment:

Drug: Fingolimod