Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
NCT ID: NCT02330965
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2014-12-31
2017-07-12
Brief Summary
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Detailed Description
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This study is part of a multi-center study, with the University of Michigan serving as the central site.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Autoimmunity Centers of Excellence
OTHER
Novartis Pharmaceuticals
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Yang Mao-Draayer, MD, PhD
Role: STUDY_CHAIR
Multiple Sclerosis Center - University of Michigan Health System
David Fox, MD
Role: STUDY_CHAIR
Division of Rheumatology - University of Michigan Health System
Locations
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Jordan Research & Education Institute: Sutter Alta Bates Summit
Berkeley, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
University of Colorado
Aurora, Colorado, United States
University of Michigan Health System -Multiple Sclerosis Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
University of New Mexico: Health Sciences Center
Albuquerque, New Mexico, United States
South Shore Neurologic Associates - Multiple Sclerosis Care Center
Patchogue, New York, United States
Carolinas Medical Center (CMC)
Charlotte, North Carolina, United States
Cleveland Clinic: Mellen Center for Multiple Sclerosis
Cleveland, Ohio, United States
Providence Multiple Sclerosis Center
Portland, Oregon, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Countries
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References
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Wu Q, Mills EA, Wang Q, Dowling CA, Fisher C, Kirch B, Lundy SK, Fox DA, Mao-Draayer Y; AMS04 Study Group. Siponimod enriches regulatory T and B lymphocytes in secondary progressive multiple sclerosis. JCI Insight. 2020 Feb 13;5(3):e134251. doi: 10.1172/jci.insight.134251.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
Relevant Clinical Trials.gov Record: NCT01665144
Other Identifiers
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DAIT AMS04
Identifier Type: -
Identifier Source: org_study_id