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

NCT01310166 | Completed Phase 4

• 2 other identifiers: CFTY720DDE012010-022066-28
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 61

Brief 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.

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multiple sclerosis; RRMS; relapsing-remitting; fingolimod; biomarkers

Outcome Measures

Primary Outcomes (5)

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

  6 Months

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

  6 months

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

  6 months

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

  6 months

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

  6 months

Secondary Outcomes (3)

• Change from baseline of B-lymphocytes

  6 months

• Change from baseline of monocytes

  6 months

• Change from baseline of Natural Killer cells

  6 months

Study Arms (1)

Fingolimod

EXPERIMENTAL

Drug: Fingolimod

Interventions

Fingolimod DRUG

Fingolimod

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
• Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (61)

Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, 73760, Germany

Location

Novartis Investigative Site

Altenholz-Stift, Germany, 24161, Germany

Location

Novartis Investigative Site

Andernach, Germany, 56626, Germany

Location

Novartis Investigative Site

Celle, Germany, 29223, Germany

Location

Novartis Investigative Site

Dortmund, Germany, 44135, Germany

Location

Novartis Investigative Site

Göttingen, Germany, 37073, Germany

Location

Novartis Investigative Site

Kastellaun, Germany, 56288, Germany

Location

Novartis Investigative Site

Kiel, Germany, 24105, Germany

Location

Novartis Investigative Site

Krefeld, Germany, 47800, Germany

Location

Novartis Investigative Site

Leipzig, Germany, 04299, Germany

Location

Novartis Investigative Site

Leverkusen, Germany, 51375, Germany

Location

Novartis Investigative Site

Mönchengladbach, Germany, 41239, Germany

Location

Novartis Investigative Site

Aalen, 73430, Germany

Location

Novartis Investigative Site

Abensberg, 93326, Germany

Location

Novartis Investigative Site

Alzenau in Unterfranken, 63755, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Bad Mergentheim, 97980, Germany

Location

Novartis Investigative Site

Bamberg, 96052, Germany

Location

Novartis Investigative Site

Berg, 82335, Germany

Location

Novartis Investigative Site

Berlin, 10437, Germany

Location

Novartis Investigative Site

Berlin, 10713, Germany

Location

Novartis Investigative Site

Berlin, 12165, Germany

Location

Novartis Investigative Site

Berlin, 13347, Germany

Location

Novartis Investigative Site

Bielefeld, 33611, Germany

Location

Novartis Investigative Site

Bochum, 44787, Germany

Location

Novartis Investigative Site

Bochum, 44789, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Böblingen, 71032, Germany

Location

Novartis Investigative Site

Bremen, 28755, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 60313, Germany

Location

Novartis Investigative Site

Fulda, 36043, Germany

Location

Novartis Investigative Site

Grevenbroich, 41515, Germany

Location

Novartis Investigative Site

Hamburg, 20249, Germany

Location

Novartis Investigative Site

Hamburg, 22083, Germany

Location

Novartis Investigative Site

Hennigsdorf, 16761, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Klingenmünster, 76889, Germany

Location

Novartis Investigative Site

Lappersdorf, 93138, Germany

Location

Novartis Investigative Site

Leipzig, 04157, Germany

Location

Novartis Investigative Site

Leverkusen, 51375, Germany

Location

Novartis Investigative Site

Merzig, 66663, Germany

Location

Novartis Investigative Site

München, 81829, Germany

Location

Novartis Investigative Site

Neuburg am Inn, 86633, Germany

Location

Novartis Investigative Site

Osnabrück, 49076, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Schwendi, 88477, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Singen, 78224, Germany

Location

Novartis Investigative Site

Stade, 21682, Germany

Location

Novartis Investigative Site

Stadtroda, 07646, Germany

Location

Novartis Investigative Site

Stuttgart, 70178, Germany

Location

Novartis Investigative Site

Troisdorf, 53844, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Ulm, 89073, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

Novartis Investigative Site

Wermsdorf, 04779, Germany

Location

Novartis Investigative Site

Wolfenbüttel, 38300, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 8, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

DE (61)