Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2)
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|ClinicalTrials.gov Identifier: NCT02325440|
Recruitment Status : Unknown
Verified December 2014 by University Hospital Muenster.
Recruitment status was: Recruiting
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
A trial in patients with relapsing remitting multiple sclerosis (RRMS)
- 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/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB).
- To evaluate changes 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.
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Remitting Multiple Sclerosis||Drug: Fingolimod Drug: Natalizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Natalizumab - Washout - Fingolimod
One experimental arm: Patients receive one final dose of natalizumab 300mg followed by an 8-week washout Phase and subsequent 32-week treatment Phase with fingolimod 0.5mg o.i.d.
Fingolimod: 0.5 mg p.o. (o.i.d)
Natalizumab: 300 mg i.v. (once at baseline);
Other Name: Tysabri
- Temporal changes in the expression of CD49d [ Time Frame: weeks: 12, 16, 20, 24, 28, 32 ]First Co-Primary Objective; Flow-cytometric analysis of temporal changes in the expression of CD49d of PBMCs; unit of measure: mean fluorescence intensity (MFI)
- Migratory capacity of immune cells [ Time Frame: weeks: 12, 32 ]Second Co-Primary Objective; in-vitro model of the blood-brain-barrier (BBB) with subsequent flow-cytometric analysis and bead based quantification assessing temporal changes in the migratory capacity of immune cells; unit of measure: fluorescence intensity
- MRI disease activity over time by GD+, T2w and DTI [ Time Frame: weeks: 0, 8, 12, 16, 24, 32 ]Number of active (new or newly enlarging) lesions are assessed over time by MRI (changes in Gadolinium (GD+), T2w lesions and DTI (Diffusion Tensor Imaging))
- MRI disease activity over time by T1w / FLAIR [ Time Frame: weeks: 0, 8, 12, 16, 24, 32 ]Number of active (new or newly enlarging) lesions are assessed over time by MRI (T1w / FLAIR (Fluid Attenuated Inversion Recovery)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325440
|Contact: Luisa Klotz, PD Dr. med.||+49 251 98029 ext firstname.lastname@example.org|
|Universitaetsklinikum Muenster, Department of Neurology||Recruiting|
|Muenster, Germany, 48149|
|Contact: Luisa Klotz, PD Dr. med. +49 251 83444 ext 52 email@example.com|
|Principal Investigator: Luisa Klotz, PD Dr. med.|
|Principal Investigator:||Luisa Klotz, PD. Dr. med.||Universitätsklinikum Muenster, Germany|