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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004616-21-DE
Enrollment
Unknown
Registered
2014-02-04
Start date
2014-03-13
Completion date
Unknown
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 descript

Sponsors

Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Secondary

MeasureTime frame
Timepoint(s) of evaluation of this end point: 24 weeks;Secondary end point(s): To evaluate change MRI disease activity upon switching from natalizumab to fingolimod treatment—

Primary

MeasureTime frame
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). ;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. ;Primary end point(s): to evaluate changes in immune function and migratory capacity of immune cells/ PBMCs upon switching from natalizumab to fingolimod treatment;Timepoint(s) of evaluation of this end point: 24 weeks—

Countries

Germany

Contacts

Public ContactCoordinating Investigator

Universitätsklinikum Münster

LuisaHildegard.Klotz@ukmuenster.de004925183444-52

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026