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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01310166

Acronym

Biobank

Enrollment

447

Registered

2011-03-08

Start date

2011-02-28

Completion date

2012-07-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multiple sclerosis, RRMS, relapsing-remitting, fingolimod, biomarkers

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.

Interventions

DRUGFingolimod

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)	6 months
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)	6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)	6 months
Change from baseline of CD8+ central 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

Measure	Time frame
Change from baseline of monocytes	6 months
Change from baseline of Natural Killer cells	6 months
Change from baseline of B-lymphocytes	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026