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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 14 March 2016
Main ID:  EUCTR2013-004616-21-DE
Date of registration: 04/02/2014
Prospective Registration: Yes
Primary sponsor: Universitätsklinikum Münster
Public title: A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya.
Scientific title: A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor
Date of first enrolment: 13/03/2014
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004616-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
Name: Coordinating Investigator   
Address:  Albert-Schweitzer-Campus 1 48149 Münster Germany
Telephone: 004925183444-52
Email: LuisaHildegard.Klotz@ukmuenster.de
Affiliation:  Universitätsklinikum Münster
Name: Coordinating Investigator   
Address:  Albert-Schweitzer-Campus 1 48149 Münster Germany
Telephone: 004925183444-52
Email: LuisaHildegard.Klotz@ukmuenster.de
Affiliation:  Universitätsklinikum Münster
Key inclusion & exclusion criteria
Inclusion criteria:
Patients aged 18-65 years with relapsing remitting multiple sclerosis and must be on natalizumab treatment for at least 12 months prior to Screening and are willing to stop natalizumab treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
Patients with a type of MS that is not relapsing, patients with history of a chronic immune disease, chrons disease, uncontrolled Diabetes, certain cancers, patients with macular edema, patients who are on certain immunosuppressive or heart medications, patients with certain hepatic, lung or heart conditions.
Other protocol defined inclusion/ exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
relapsing remitting multiple sclerosis
MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: BG00002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)
Main Objective: - To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d.
- To evaluate changes in the migratory capacity of immune cells/PBMCs upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB).
Primary end point(s): to evaluate changes in immune function and migratory capacity of immune cells/ PBMCs upon switching from natalizumab to fingolimod treatment
Secondary Objective: - To evaluate a change in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in GD+, T2w lesions and DTI).
- To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod.
Timepoint(s) of evaluation of this end point: 24 weeks
Secondary Outcome(s)
Secondary end point(s): To evaluate change MRI disease activity upon switching from natalizumab to fingolimod treatment
Timepoint(s) of evaluation of this end point: 24 weeks
Secondary ID(s)
CFTY720D2415T
Source(s) of Monetary Support
Novartis Pharma GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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