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Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Advancing RMS Patients. (EXCHANGE)

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ClinicalTrials.gov Identifier: NCT03623243
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To assess early phase safety and tolerability of converting patients from approved oral and injectable RMS DMTs to siponimod. The results of this study will guide clinically relevant decisions related to the transition from frequently used RMS DMTs to siponimod and provide clinically relevant data on safety and tolerability for healthcare providers who are considering converting patients from currently approved RMS DMT to siponimod.

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

Detailed Description:
This is a 6-month, open-label, multi-center, single arm design, including 300 advancing RMS patients, evaluating overall safety and tolerability profile when acutely converting to siponimod from oral or injectable RMS DMT.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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 or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 (BAF312)
Siponimod 2mg
Drug: Siponimod
S1P1 and S1P5 receptor agonist




Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 6 months ]
    safety and tolerability after converting from DMTs.


Secondary Outcome Measures :
  1. Number of patients satisfied with treatment [ Time Frame: 6 months ]
    patient satisfaction

  2. Adherence [ Time Frame: 6 months ]
    percent of patients who adhere to therapy



Information from the National Library of Medicine

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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 must be obtained prior to participation in the study.
  2. Male or female aged 18 to 65 years (inclusive) at screening
  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 oral or injectable RMS DMTs

Key Exclusion criteria:

  1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  2. Patients with any medically unstable condition as determine by the investigator.
  3. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

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): NCT03623243


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

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03623243     History of Changes
Other Study ID Numbers: CBAF312AUS02
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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; Advancing Multiple Sclerosis; conversion; siponimod;

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