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NCT01310166 Clinical Trial

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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— Biobank  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01310166
Other study ID # CFTY720DDE01
Secondary ID 2010-022066-28
Status Completed
Phase Phase 4
First received February 24, 2011
Last updated November 16, 2016
Start date February 2011
Est. completion date July 2012

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 447
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Fingolimod

Locations
Country Name City State
Germany Novartis Investigative Site Aalen
Germany Novartis Investigative Site Abensberg
Germany Novartis Investigative Site Altenholz-Stift
Germany Novartis Investigative Site Alzenau
Germany Novartis Investigative Site Andernach
Germany Novartis Investigative Site Aschaffenburg
Germany Novartis Investigative Site Bad Mergentheim
Germany Novartis Investigative Site Bamberg
Germany Novartis Investigative Site Berg
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Böblingen
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bremen
Germany Novartis Investigative Site Celle
Germany Novartis Investigative Site Dortmund
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Düsseldorf
Germany Novartis Investigative Site Erbach
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Fulda
Germany Novartis Investigative Site Göttingen
Germany Novartis Investigative Site Grevenbroich
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hennigsdorf
Germany Novartis Investigative Site Jena
Germany Novartis Investigative Site Kastellaun
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Klingenmünster
Germany Novartis Investigative Site Krefeld
Germany Novartis Investigative Site Lappersdorf
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leverkusen
Germany Novartis Investigative Site Merzig
Germany Novartis Investigative Site Mönchengladbach
Germany Novartis Investigative Site München
Germany Novartis Investigative Site Neuburg
Germany Novartis Investigative Site Osnabrück
Germany Novartis Investigative Site Ostfildern Baden-Wuerttemberg
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Schwendi
Germany Novartis Investigative Site Siegen
Germany Novartis Investigative Site Singen
Germany Novartis Investigative Site Stade
Germany Novartis Investigative Site Stadtroda
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative Site Troisdorf
Germany Novartis Investigative Site Tübingen
Germany Novartis Investigative Site Ulm
Germany Novartis Investigative Site Unterhaching
Germany Novartis Investigative Site Wermsdorf
Germany Novartis Investigative Site Wolfenbüttel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) 6 Months No
Primary Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+) 6 months No
Primary Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-) 6 months No
Primary Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-) 6 months No
Primary Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-) 6 months No
Secondary Change from baseline of B-lymphocytes 6 months No
Secondary Change from baseline of monocytes 6 months No
Secondary Change from baseline of Natural Killer cells 6 months No
See also
  Status Clinical Trial Phase
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Terminated NCT01790269 - Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Terminated NCT01701856 - Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis Phase 4
Completed NCT00525668 - Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) Phase 1/Phase 2
Terminated NCT00398528 - An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis Phase 4
Completed NCT00315367 - A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties Phase 4
Terminated NCT04032171 - Study of Evobrutinib in Participants With RMS Phase 3
Completed NCT01930708 - A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes Phase 4
Completed NCT03000647 - Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis N/A
Completed NCT02205489 - Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA Phase 4
Completed NCT02753088 - Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis Phase 3
Recruiting NCT01466114 - Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition Phase 2
Completed NCT01416155 - Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis Phase 2
Completed NCT01244139 - Safety Study of BIIB033 in Subjects With Multiple Sclerosis Phase 1
Completed NCT00559702 - Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Phase 1
Completed NCT00493116 - Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta Phase 4
Terminated NCT01706107 - Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Completed NCT01943526 - Ireland Natalizumab (TYSABRI) Observational Program

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