Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT01310166
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
447 participants
INTERVENTIONAL
2011-02-28
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Fingolimod
Fingolimod
Interventions
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Fingolimod
Eligibility Criteria
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Inclusion Criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, Germany
Novartis Investigative Site
Altenholz-Stift, Germany, Germany
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Andernach, Germany, Germany
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Celle, Germany, Germany
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Dortmund, Germany, Germany
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Göttingen, Germany, Germany
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Kastellaun, Germany, Germany
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Kiel, Germany, Germany
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Krefeld, Germany, Germany
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Leipzig, Germany, Germany
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Leverkusen, Germany, Germany
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Mönchengladbach, Germany, Germany
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Aalen, , Germany
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Abensberg, , Germany
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Alzenau in Unterfranken, , Germany
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Aschaffenburg, , Germany
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Bad Mergentheim, , Germany
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Bamberg, , Germany
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Berg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Böblingen, , Germany
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Bremen, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Erbach im Odenwald, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Fulda, , Germany
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Grevenbroich, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hennigsdorf, , Germany
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Jena, , Germany
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Klingenmünster, , Germany
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Lappersdorf, , Germany
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Leipzig, , Germany
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Leverkusen, , Germany
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Merzig, , Germany
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München, , Germany
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Neuburg am Inn, , Germany
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Osnabrück, , Germany
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Regensburg, , Germany
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Schwendi, , Germany
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Siegen, , Germany
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Singen, , Germany
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Stade, , Germany
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Stadtroda, , Germany
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Stuttgart, , Germany
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Troisdorf, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Unterhaching, , Germany
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Wermsdorf, , Germany
Novartis Investigative Site
Wolfenbüttel, , Germany
Countries
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Other Identifiers
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2010-022066-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720DDE01
Identifier Type: -
Identifier Source: org_study_id