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Completed

NCT Number: NCT01310166

Biomarker Study After Initiation of Treatment With 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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ostfildern, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod

Drug

Primary outcomes

  1. Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)

    Time frame: 6 Months

  2. Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)

    Time frame: 6 months

  3. Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)

    Time frame: 6 months

  4. Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)

    Time frame: 6 months

  5. Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline of B-lymphocytes

    Time frame: 6 months

  2. Change from baseline of monocytes

    Time frame: 6 months

  3. Change from baseline of Natural Killer cells

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: Biobank

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2011
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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