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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02330965
Registration number
NCT02330965
Ethics application status
Date submitted
31/12/2014
Date registered
5/01/2015
Date last updated
9/11/2020
Titles & IDs
Public title
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
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Scientific title
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
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Secondary ID [1]
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DAIT AMS04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Blood Draw
Treatment: Surgery - CSF collection by lumbar puncture (Optional)
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.
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.
Treatment: Surgery: 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.
Treatment: Surgery: 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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in frequency of MBP-reactive Th17 cells
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Assessment method [1]
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Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot.
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Timepoint [1]
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From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
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Secondary outcome [1]
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Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells
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Assessment method [1]
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Compare BAF312 and Placebo (Control) Groups
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Timepoint [1]
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From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
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Secondary outcome [2]
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Change in chemokine and cytokines levels
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Assessment method [2]
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Compare BAF312 and Placebo (Control) Groups
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Timepoint [2]
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From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
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Secondary outcome [3]
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Change in Regulatory B Cells
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Assessment method [3]
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Compare BAF312 and Placebo (Control) Groups
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Timepoint [3]
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From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
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Secondary outcome [4]
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Changes of clinical status and lymphocyte subgroups
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Assessment method [4]
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Compare BAF312 and Placebo (Control) Groups
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Timepoint [4]
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From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/07/2017
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Sample size
Target
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Michigan
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Minnesota
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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State/province [10]
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Washington
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Allergy and Infectious Diseases (NIAID)
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Autoimmunity Centers of Excellence
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Novartis Pharmaceuticals
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Address [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02330965
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Yang Mao-Draayer, MD, PhD
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Address
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Multiple Sclerosis Center - University of Michigan Health System
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02330965
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