Disease Control in RRMS Transferring Treatment From Natalizumab to Fingolimod

NCT02277964 | Completed

• 1 other identifier: CFTY720D2324
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

RRMS; Natalizumab; Fingolimod; Treatment Change; Disease Activity

Outcome Measures

Primary Outcomes (2)

• Relapse rate

  up to 108 Weeks

• New or newly enlarging lesions/Gadolinium enhancing lesions

  up to 108 Weeks

Secondary Outcomes (1)

• Immunological markers

  Weeks 0, 8, 12, 16, 20

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing remitting multiple sclerosis, who are planned to change treatment from natalizumab to fingolimod

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Novartis: collaborator

Study Sites (1)

University Hospital Basel, Switzerland

Basel, 4031, Switzerland

Location

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

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos, Prof., MD

  Department of Neurology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: March 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

CH (1)