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Trial record 6 of 6 for:    siponimod

Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02330965
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
Autoimmunity Centers of Excellence
Novartis Pharmaceuticals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date December 31, 2014
First Posted Date January 5, 2015
Last Update Posted Date November 7, 2017
Study Start Date December 2014
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2016)
Change in frequency of MBP-reactive Th17 cells [ Time Frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). ]
Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot.
Original Primary Outcome Measures
 (submitted: December 31, 2014)
Change in frequency of MBP-reactive Th17 cells [ Time Frame: From baseline to months 6, 12 and 24 ]
Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot.
Change History Complete list of historical versions of study NCT02330965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 25, 2016)
  • Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells [ Time Frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). ]
    Compare BAF312 and Placebo (Control) Groups
  • Change in chemokine and cytokines levels [ Time Frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). ]
    Compare BAF312 and Placebo (Control) Groups
  • Change in Regulatory B Cells [ Time Frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). ]
    Compare BAF312 and Placebo (Control) Groups
  • Changes of clinical status and lymphocyte subgroups [ Time Frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). ]
    Compare BAF312 and Placebo (Control) Groups
Original Secondary Outcome Measures
 (submitted: December 31, 2014)
  • Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells [ Time Frame: From baseline to months 6, 12 and 24 ]
    Compare BAF312 and Placebo (Control) Groups
  • Change in chemokine and cytokines levels [ Time Frame: From baseline to months 6, 12, and 24 ]
    Compare BAF312 and Placebo (Control) Groups
  • Change in Regulatory B Cells [ Time Frame: From baseline to months 6, 12 and 24 ]
    Compare BAF312 and Placebo (Control) Groups
  • Changes of clinical status and lymphocyte subgroups [ Time Frame: From baseline to months 6, 12 and 24 ]
    Compare BAF312 and Placebo (Control) Groups
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Official Title Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Brief Summary The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
Detailed Description

This study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the setting of a SPMS clinical trial.

This study is part of a multi-center study, with the University of Michigan serving as the central site.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood & Cerebrospinal Fluid Samples
Sampling Method Non-Probability Sample
Study Population

Ambulatory participants with Secondary Progressive Multiple Sclerosis (SPMS) enrolled in the EXPAND trial (BAF312 treated and placebo [control] participants) may be enrolled in this study after the EXPAND baseline visit has occurred provided that the subject has not passed the Month 12 time point.

-Refer to ClinicalTrials.gov record NCT01665144.

Condition Secondary Progressive Multiple Sclerosis
Intervention
  • Procedure: Blood Draw
    Blood draws (65 mLs [~4 tablespoons] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.
    Other Names:
    • Phlebotomy
    • Venipuncture
  • Procedure: CSF collection by lumbar puncture (Optional)
    For participants who volunteer to donate CSF samples: up to 25 mLs (<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.
    Other Names:
    • CSF by LP
    • cerebrospinal fluid collected by lumbar puncture
Study Groups/Cohorts
  • Subjects Assigned to BAF312
    Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive BAF312 (siponimod). Refer to ClinicalTrials.gov record NCT01665144 for more information.
    Interventions:
    • Procedure: Blood Draw
    • Procedure: CSF collection by lumbar puncture (Optional)
  • Subjects Assigned to Placebo (Controls)
    Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive placebo. Refer to ClinicalTrials.gov record NCT01665144 for more information.
    Interventions:
    • Procedure: Blood Draw
    • Procedure: CSF collection by lumbar puncture (Optional)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2016)
40
Original Estimated Enrollment
 (submitted: December 31, 2014)
75
Actual Study Completion Date July 12, 2017
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov record NCT01665144.
  • Subjects enrolled at one of the participating AMS04 study sites located in the United States.
  • Subject must be able to provide written informed consent.

Exclusion Criteria:

  • Subjects with severe bleeding disorders, platelet count less than (<)50,000/microliters (μL), and/or who are currently on full anticoagulant therapy will be excluded from the optional CSF collections.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02330965
Other Study ID Numbers DAIT AMS04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
  • Autoimmunity Centers of Excellence
  • Novartis Pharmaceuticals
Investigators
Study Chair: Yang Mao-Draayer, MD, PhD Multiple Sclerosis Center - University of Michigan Health System
Study Chair: David Fox, MD Division of Rheumatology - University of Michigan Health System
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2017