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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)

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.

Condition or disease Intervention/treatment
Secondary Progressive Multiple Sclerosis Procedure: Blood Draw Procedure: CSF collection by lumbar puncture (Optional)

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Study Start Date : December 2014
Actual Primary Completion Date : July 12, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Biospecimen Retention:   Samples With DNA
Blood & Cerebrospinal Fluid Samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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): NCT02330965


Locations
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United States, California
Jordan Research & Education Institute: Sutter Alta Bates Summit
Berkeley, California, United States, 94705
University of Southern California
Los Angeles, California, United States, 90033
University of California, Davis
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan Health System -Multiple Sclerosis Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
United States, New Mexico
University of New Mexico: Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, New York
South Shore Neurologic Associates - Multiple Sclerosis Care Center
Patchogue, New York, United States, 11772
United States, North Carolina
Carolinas Medical Center (CMC)
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cleveland Clinic: Mellen Center for Multiple Sclerosis
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Multiple Sclerosis Center
Portland, Oregon, United States, 97225
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence
Novartis Pharmaceuticals
Investigators
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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

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02330965     History of Changes
Other Study ID Numbers: DAIT AMS04
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
clinical research
mechanistic studies
blood draw
CSF by lumbar puncture (optional)

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms