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

November 16, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany, 73430
        • Novartis Investigative Site
      • Abensberg, Germany, 93326
        • Novartis Investigative Site
      • Altenholz-Stift, Germany, 24161
        • Novartis Investigative Site
      • Alzenau, Germany, 63755
        • Novartis Investigative Site
      • Andernach, Germany, 56626
        • Novartis Investigative Site
      • Aschaffenburg, Germany, 63739
        • Novartis Investigative Site
      • Bad Mergentheim, Germany, 97980
        • Novartis Investigative Site
      • Bamberg, Germany, 96052
        • Novartis Investigative Site
      • Berg, Germany, 82335
        • Novartis Investigative Site
      • Berlin, Germany, 10713
        • Novartis Investigative Site
      • Berlin, Germany, 12165
        • Novartis Investigative Site
      • Berlin, Germany, 13347
        • Novartis Investigative Site
      • Berlin, Germany, 10437
        • Novartis Investigative Site
      • Bielefeld, Germany, 33611
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Novartis Investigative Site
      • Bochum, Germany, 44787
        • Novartis Investigative Site
      • Bochum, Germany, 44789
        • Novartis Investigative Site
      • Bremen, Germany, 28755
        • Novartis Investigative Site
      • Böblingen, Germany, 71032
        • Novartis Investigative Site
      • Celle, Germany, 29223
        • Novartis Investigative Site
      • Dortmund, Germany, 44135
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Düsseldorf, Germany, 40225
        • Novartis Investigative Site
      • Erbach, Germany, 64711
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Frankfurt, Germany, 60313
        • Novartis Investigative Site
      • Fulda, Germany, 36043
        • Novartis Investigative Site
      • Grevenbroich, Germany, 41515
        • Novartis Investigative Site
      • Göttingen, Germany, 37073
        • Novartis Investigative Site
      • Hamburg, Germany, 22083
        • Novartis Investigative Site
      • Hamburg, Germany, 20249
        • Novartis Investigative Site
      • Hennigsdorf, Germany, 16761
        • Novartis Investigative Site
      • Jena, Germany, 07740
        • Novartis Investigative Site
      • Kastellaun, Germany, 56288
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Klingenmünster, Germany, 76889
        • Novartis Investigative Site
      • Krefeld, Germany, 47800
        • Novartis Investigative Site
      • Lappersdorf, Germany, 93138
        • Novartis Investigative Site
      • Leipzig, Germany, 04157
        • Novartis Investigative Site
      • Leipzig, Germany, 04299
        • Novartis Investigative Site
      • Leverkusen, Germany, 51375
        • Novartis Investigative Site
      • Merzig, Germany, 66663
        • Novartis Investigative Site
      • Mönchengladbach, Germany, 41239
        • Novartis Investigative Site
      • München, Germany, 81829
        • Novartis Investigative Site
      • Neuburg, Germany, 86633
        • Novartis Investigative Site
      • Osnabrück, Germany, 49076
        • Novartis Investigative Site
      • Regensburg, Germany, 93053
        • Novartis Investigative Site
      • Schwendi, Germany, 88477
        • Novartis Investigative Site
      • Siegen, Germany, 57076
        • Novartis Investigative Site
      • Singen, Germany, 78224
        • Novartis Investigative Site
      • Stade, Germany, 21682
        • Novartis Investigative Site
      • Stadtroda, Germany, 07646
        • Novartis Investigative Site
      • Stuttgart, Germany, 70178
        • Novartis Investigative Site
      • Troisdorf, Germany, 53844
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Novartis Investigative Site
      • Ulm, Germany, 89073
        • Novartis Investigative Site
      • Unterhaching, Germany, 82008
        • Novartis Investigative Site
      • Wermsdorf, Germany, 04779
        • Novartis Investigative Site
      • Wolfenbüttel, Germany, 38300
        • Novartis Investigative Site
    • Baden-Wuerttemberg
      • Ostfildern, Baden-Wuerttemberg, Germany, 73760
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fingolimod
Drug: Fingolimod

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of B-lymphocytes
Time Frame: 6 months
6 months
Change from baseline of monocytes
Time Frame: 6 months
6 months
Change from baseline of Natural Killer cells
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720DDE01
  • 2010-022066-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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