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Trial record 1 of 1 for:    CBAF312AUS02
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Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. (EXCHANGE)

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ClinicalTrials.gov Identifier: NCT03623243
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Relapsing Multiple Sclerosis Advancing Multiple Sclerosis Drug: Siponimod Phase 3

Detailed Description:
This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : June 7, 2022
Estimated Study Completion Date : July 8, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Siponimod

Arms and Interventions
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Arm Intervention/treatment
Experimental: Siponimod 2 mg
Siponimod 2mg tablets taken once daily after a 5 day titration
 Drug: Siponimod
Siponimod 2mg tablets taken once daily
Other Name: BAF312


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with treatment emergent adverse events [ Time Frame: Baseline up to 6 months ]
    Adverse events considered to be drug related will be collected to assess safety and tolerability at scheduled visits after converting from disease modifying therapies


Secondary Outcome Measures :
  1. Number of patients satisfied with treatment as measured by Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline up to 6 months ]
    TSQM9 - Treatment Satisfaction Questionnaire for Medication: measures patient satisfaction with the medication in 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.

  2. Change in Heart Rate from baseline [ Time Frame: Baseline to 6 hours post initial treatment ]
    Heart rate will be evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor

  3. Treatment persistence with Siponimod [ Time Frame: Baseline up to 6 months ]
    Patient retention will be assessed over the study period. Treatment compliance is defined as being 80% adherent and will be assessed via drug accountability performed at the site.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Signed informed consent.
  2. Male or female aged 18 to 65 years (inclusive).
  3. Patients with advancing RMS as defined by the principal investigator.
  4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
  5. EDSS score of >/= 2.0 to 6.5 (inclusive).
  6. Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

  1. Pregnant or nursing (lactating) women.
  2. Patients with any medically unstable condition as determined by the investigator.
  3. Certain cardiac risk factors defined in the protocol
  4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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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): NCT03623243


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

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03623243    
Other Study ID Numbers: CBAF312AUS02
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple sclerosis
Relapsing multiple sclerosis
Advancing multiple sclerosis
conversion
siponimod
 adult
BAF312
disease modifying therapies
cognitive assessment
open-label
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Siponimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs