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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01310166
Collaborator
(none)
447
Enrollment
60
Locations
1
Arm
17
Duration (Months)
7.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
447 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fingolimod

Drug: Fingolimod

Outcome Measures

Primary Outcome Measures

  1. Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) [6 Months]

  2. Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+) [6 months]

  3. Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-) [6 months]

  4. Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-) [6 months]

  5. Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-) [6 months]

Secondary Outcome Measures

  1. Change from baseline of B-lymphocytes [6 months]

  2. Change from baseline of monocytes [6 months]

  3. Change from baseline of Natural Killer cells [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Ostfildern Baden-Wuerttemberg Germany 73760
2 Novartis Investigative Site Aalen Germany 73430
3 Novartis Investigative Site Abensberg Germany 93326
4 Novartis Investigative Site Altenholz-Stift Germany 24161
5 Novartis Investigative Site Alzenau Germany 63755
6 Novartis Investigative Site Andernach Germany 56626
7 Novartis Investigative Site Aschaffenburg Germany 63739
8 Novartis Investigative Site Bad Mergentheim Germany 97980
9 Novartis Investigative Site Bamberg Germany 96052
10 Novartis Investigative Site Berg Germany 82335
11 Novartis Investigative Site Berlin Germany 10437
12 Novartis Investigative Site Berlin Germany 10713
13 Novartis Investigative Site Berlin Germany 12165
14 Novartis Investigative Site Berlin Germany 13347
15 Novartis Investigative Site Bielefeld Germany 33611
16 Novartis Investigative Site Bochum Germany 44787
17 Novartis Investigative Site Bochum Germany 44789
18 Novartis Investigative Site Bochum Germany 44791
19 Novartis Investigative Site Bremen Germany 28755
20 Novartis Investigative Site Böblingen Germany 71032
21 Novartis Investigative Site Celle Germany 29223
22 Novartis Investigative Site Dortmund Germany 44135
23 Novartis Investigative Site Dresden Germany 01307
24 Novartis Investigative Site Düsseldorf Germany 40225
25 Novartis Investigative Site Erbach Germany 64711
26 Novartis Investigative Site Erlangen Germany 91054
27 Novartis Investigative Site Frankfurt Germany 60313
28 Novartis Investigative Site Fulda Germany 36043
29 Novartis Investigative Site Grevenbroich Germany 41515
30 Novartis Investigative Site Göttingen Germany 37073
31 Novartis Investigative Site Hamburg Germany 20249
32 Novartis Investigative Site Hamburg Germany 22083
33 Novartis Investigative Site Hennigsdorf Germany 16761
34 Novartis Investigative Site Jena Germany 07740
35 Novartis Investigative Site Kastellaun Germany 56288
36 Novartis Investigative Site Kiel Germany 24105
37 Novartis Investigative Site Klingenmünster Germany 76889
38 Novartis Investigative Site Krefeld Germany 47800
39 Novartis Investigative Site Lappersdorf Germany 93138
40 Novartis Investigative Site Leipzig Germany 04157
41 Novartis Investigative Site Leipzig Germany 04299
42 Novartis Investigative Site Leverkusen Germany 51375
43 Novartis Investigative Site Merzig Germany 66663
44 Novartis Investigative Site Mönchengladbach Germany 41239
45 Novartis Investigative Site München Germany 81829
46 Novartis Investigative Site Neuburg Germany 86633
47 Novartis Investigative Site Osnabrück Germany 49076
48 Novartis Investigative Site Regensburg Germany 93053
49 Novartis Investigative Site Schwendi Germany 88477
50 Novartis Investigative Site Siegen Germany 57076
51 Novartis Investigative Site Singen Germany 78224
52 Novartis Investigative Site Stade Germany 21682
53 Novartis Investigative Site Stadtroda Germany 07646
54 Novartis Investigative Site Stuttgart Germany 70178
55 Novartis Investigative Site Troisdorf Germany 53844
56 Novartis Investigative Site Tübingen Germany 72076
57 Novartis Investigative Site Ulm Germany 89073
58 Novartis Investigative Site Unterhaching Germany 82008
59 Novartis Investigative Site Wermsdorf Germany 04779
60 Novartis Investigative Site Wolfenbüttel Germany 38300

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01310166
Other Study ID Numbers:
  • CFTY720DDE01
  • 2010-022066-28
First Posted:
Mar 8, 2011
Last Update Posted:
Nov 18, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Novartis Pharmaceuticals
Multiple sclerosis
RRMS
relapsing-remitting
fingolimod
biomarkers
Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Fingolimod Hydrochloride

Study Results

No Results Posted as of Nov 18, 2016