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A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod (FLUENT)

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ClinicalTrials.gov Identifier: NCT03257358
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Fingolimod Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-cohort, non-randomized, open-label multicenter
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cohort 1
RMS patients who are newly prescribed commercially available fingolimod 0.5mg per day
Drug: Fingolimod
Commercially available 0.5mg hard capsules, taken orally once per day

Cohort 2
RMS patients who have been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
Drug: Fingolimod
Commercially available 0.5mg hard capsules, taken orally once per day




Primary Outcome Measures :
  1. Change in CD4+ and CD8+ naïve T-cells, central memory T-cells, and effector memory T-cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.

  2. Change in CD4+ Th1, Th2, and Th17 cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.

  3. Change in naïve B-cells, memory B-cells, and regulatory B-cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.

  4. Change in monocytes, neutrophils, and NK cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.


Secondary Outcome Measures :
  1. Change in anti-JCV antibody status (+ or -) / index from baseline to Months 3, 6, and 12. [ Time Frame: Baseline to Months 3, 6, and 12 ]
    Blood samples will be collected to assess this outcome.

  2. Association of change in anti-JCV antibody status/index and change in CD4+ and CD8+ naïve T-cells, central memory T-cells, and effector memory T-cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.

  3. Association of change in anti-JCV antibody status/index and change in CD4+ Th1, Th2, and Th17 cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.

  4. Association of change in anti-JCV antibody status/index and change in naïve B-cells, memory B-cells, and regulatory B-cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.

  5. Association of change in anti-JCV antibody status/index and change in monocytes, neutrophils and NK cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsing forms of Multiple Sclerosis
  • Patients who will start commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

  • Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
  • History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker
  • Baseline QTc interval ≥ 500 msec
  • Treatment with Class Ia or Class III anti-arrhythmic drugs
  • Patients who have had a hypersensitivity reaction to fingolimod or any of the excipients

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT03257358


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

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Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03257358     History of Changes
Other Study ID Numbers: CFTY720DUS40
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Relapsing Multiple Sclerosis
RMS
Relapsing Multiple Sclerosis (RMS)
Multiple Sclerosis
MS
Multiple Sclerosis (MS)
Fingolimod
FLUENT
Immune Phenotype

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs