Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Disease Control in RRMS Transferring Treatment From Natalizumab to Fingolimod

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277964
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

This is an observational study to develop new hypothesis regarding the dynamic and safety of switching from natalizumab to fingolimod:

  • Comparison of disease activity (clinical and MRI) during the year after change of therapy in comparison to the year before change
  • Dynamic of onset of disease activity after having stopped treatment with natalizumab
  • Change of immunological parameters during treatment change from natalizumab to fingolimod in comparison to clinical and MRI measures

Condition or disease
Relapsing Remitting Multiple Sclerosis

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Evaluate Disease Control, Safety and Immunological Changes in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Transferred From Previous Treatment With Natalizumab to Fingolimod.
Study Start Date : March 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort
RRMS with treatment change

All patients with treatment change from natalizumab 300mg iv monthly to fingolimod 0.5mg orally/daily.

16 patients were switched with an interval of 8 weeks until october 2013. After an interims analysis the interval has been changed to 4 weeks (after october 2013).




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: up to 108 Weeks ]
  2. New or newly enlarging lesions/Gadolinium enhancing lesions [ Time Frame: up to 108 Weeks ]

Secondary Outcome Measures :
  1. Immunological markers [ Time Frame: Weeks 0, 8, 12, 16, 20 ]

Biospecimen Retention:   Samples Without DNA
  • assess alterations of the composition of myeloid cells and lymphocyte subpopulations (i.e. naïve, central memory and effector memory and regulatory T cells, B cells) and adhesion molecule expression in peripheral blood
  • measure autoantigen specific T cell proliferation and IFNγ production
  • characterize transcriptomic alterations (including mRNA and small non-coding RNA expression) in lymphocytes of MS-patients
  • assess changes in plasma cytokine, chemokine, and Matrix metallo-proteinase levels
  • assess the migratory capacity of PBMCs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsing remitting multiple sclerosis, who are planned to change treatment from natalizumab to fingolimod
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18-65 years
  • Subjects with RRMS, defined by 2010 revised McDonald criteria
  • Patients with Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
  • Patients on treatment with natalizumab for at least 6 months prior to screening

Exclusion Criteria:

  • Patients with serious cardiovascular conditions and/or history or presence of a second- and third-degree aortic valve (AV) block, corrected QT interval (QTc) >450 ms in males and >470 ms in females
  • Patients receiving class Ia or III antiarrhythmic drugs
  • Patients with proven history of sick sinus Syndrome (SSS) or sinoatrial (SA) heart block
  • Patients with uncontrolled hypertension
  • Patients with resting heart rate (HR) <45 bpm
  • Patients who have been treated with Fingolimod or cladribine at any time
  • Patients with a history of malignancy of any organ system
  • Patients with severe respiratory or hepatic disease

Information from the National Library of Medicine

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): NCT02277964


Locations
Layout table for location information
Switzerland
University Hospital Basel, Switzerland
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Novartis
Investigators
Layout table for investigator information
Principal Investigator: Ludwig Kappos, Prof., MD Department of Neurology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland

Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02277964    
Other Study ID Numbers: CFTY720D2324
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by University Hospital, Basel, Switzerland:
RRMS
Natalizumab
Fingolimod
Treatment Change
Disease Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Fingolimod Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents