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

Phase 4

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT01310166
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod	Fingolimod	-

Primary Outcome Measures

Name	Time	Method
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)	6 months
Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)	6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)	6 months
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)	6 months
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)	6 Months

Secondary Outcome Measures

Name	Time	Method
Change from baseline of Natural Killer cells	6 months
Change from baseline of B-lymphocytes	6 months
Change from baseline of monocytes	6 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wolfenbüttel, Germany