NCT01310166CompletedPhase 4
A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 447
- Locations
- 1
- Primary Endpoint
- Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fingolimod
Experimental
Intervention: Fingolimod (Drug)
Outcomes
Primary Outcomes
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
Time Frame: 6 months
Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)
Time Frame: 6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)
Time Frame: 6 months
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)
Time Frame: 6 months
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)
Time Frame: 6 Months
Secondary Outcomes
- Change from baseline of Natural Killer cells(6 months)
- Change from baseline of B-lymphocytes(6 months)
- Change from baseline of monocytes(6 months)
Investigators
Study Sites (1)
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