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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01310166
First received: February 24, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
Drug: Fingolimod
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of B-lymphocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of monocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of Natural Killer cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 531
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod Drug: Fingolimod

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310166

  Show 60 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01310166     History of Changes
Other Study ID Numbers: CFTY720DDE01, 2010-022066-28
Study First Received: February 24, 2011
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Multiple sclerosis
RRMS
relapsing-remitting
fingolimod
biomarkers

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014