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Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya

NCT02325440 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-12-25

No results posted yet for this study

Summary

A trial in patients with relapsing remitting multiple sclerosis (RRMS)

Main objectives:

* 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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Fingolimod

Fingolimod: 0.5 mg p.o. (o.i.d)

DRUG

Natalizumab

Natalizumab: 300 mg i.v. (once at baseline);

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Luisa Klotz, PD. Dr. med. · Universitätsklinikum Muenster, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02325440 on ClinicalTrials.gov