Clinical trial NCT01310166: Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple sclerosis
RRMS
relapsing-remitting
fingolimod
biomarkers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-08
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)
timeFrame: 6 Months
measure: Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
timeFrame: 6 months
measure: Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)
timeFrame: 6 months
measure: Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)
timeFrame: 6 months
measure: Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline of B-lymphocytes
timeFrame: 6 months
measure: Change from baseline of monocytes
timeFrame: 6 months
measure: Change from baseline of Natural Killer cells
timeFrame: 6 months
Other outcomes:
Locations:
city: Ostfildern
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Aalen
country: Germany
facility: Novartis Investigative Site
city: Abensberg
country: Germany
facility: Novartis Investigative Site
city: Altenholz-Stift
country: Germany
facility: Novartis Investigative Site
city: Alzenau
country: Germany
facility: Novartis Investigative Site
city: Andernach
country: Germany
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Bad Mergentheim
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Böblingen
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Erbach
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Grevenbroich
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hennigsdorf
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kastellaun
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Klingenmünster
country: Germany
facility: Novartis Investigative Site
city: Krefeld
country: Germany
facility: Novartis Investigative Site
city: Lappersdorf
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leverkusen
country: Germany
facility: Novartis Investigative Site
city: Merzig
country: Germany
facility: Novartis Investigative Site
city: Mönchengladbach
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Neuburg
country: Germany
facility: Novartis Investigative Site
city: Osnabrück
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Schwendi
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Singen
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stadtroda
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Unterhaching
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
city: Wolfenbüttel
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: