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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Fingolimod

About this trial

This is an interventional basic science trial for Relapsing-remitting Multiple Sclerosis focused on measuring Multiple sclerosis, RRMS, relapsing-remitting, fingolimod, biomarkers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

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

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

Secondary Outcome Measures

Change from baseline of B-lymphocytes

Change from baseline of monocytes

Change from baseline of Natural Killer cells

Full Information

NCT ID

NCT01310166

First Posted

February 24, 2011

Last Updated

November 16, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01310166

Brief Title

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

Acronym

Biobank

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-remitting Multiple Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

447 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Primary Outcome Measure Information:

Title

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

Time Frame

6 Months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change from baseline of B-lymphocytes

Time Frame

6 months

Title

Change from baseline of monocytes

Time Frame

6 months

Title

Change from baseline of Natural Killer cells

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Ostfildern

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73760

Country

Germany

Facility Name

Novartis Investigative Site

City

Aalen

ZIP/Postal Code

73430

Country

Germany

Facility Name

Novartis Investigative Site

City

Abensberg

ZIP/Postal Code

93326

Country

Germany

Facility Name

Novartis Investigative Site

City

Altenholz-Stift

ZIP/Postal Code

24161

Country

Germany

Facility Name

Novartis Investigative Site

City

Alzenau

ZIP/Postal Code

63755

Country

Germany

Facility Name

Novartis Investigative Site

City

Andernach

ZIP/Postal Code

56626

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96052

Country

Germany

Facility Name

Novartis Investigative Site

City

Berg

ZIP/Postal Code

82335

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12165

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33611

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28755

Country

Germany

Facility Name

Novartis Investigative Site

City

Böblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Celle

ZIP/Postal Code

29223

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44135

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

Novartis Investigative Site

City

Grevenbroich

ZIP/Postal Code

41515

Country

Germany

Facility Name

Novartis Investigative Site

City

Göttingen

ZIP/Postal Code

37073

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

Novartis Investigative Site

City

Hennigsdorf

ZIP/Postal Code

16761

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Kastellaun

ZIP/Postal Code

56288

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Klingenmünster

ZIP/Postal Code

76889

Country

Germany

Facility Name

Novartis Investigative Site

City

Krefeld

ZIP/Postal Code

47800

Country

Germany

Facility Name

Novartis Investigative Site

City

Lappersdorf

ZIP/Postal Code

93138

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04157

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04299

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Facility Name

Novartis Investigative Site

City

Merzig

ZIP/Postal Code

66663

Country

Germany

Facility Name

Novartis Investigative Site

City

Mönchengladbach

ZIP/Postal Code

41239

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81829

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwendi

ZIP/Postal Code

88477

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Singen

ZIP/Postal Code

78224

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Troisdorf

ZIP/Postal Code

53844

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Wermsdorf

ZIP/Postal Code

04779

Country

Germany

Facility Name

Novartis Investigative Site

City

Wolfenbüttel

ZIP/Postal Code

38300

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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

Relapsing-remitting Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial