Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Blood Draw
- CSF collection by lumbar puncture (Optional)
What it measured
Main measures
Change in frequency of MBP-reactive Th17 cells
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Immune response
Other measures (4)
Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Immune responseChange in chemokine and cytokines levels
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Immune responseChange in Regulatory B Cells
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Immune responseChanges of clinical status and lymphocyte subgroups
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Immune response
Who could take part
Progressive MS · 18 to 60
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Linked trials
Sub-study of
Exploring the Efficacy and Safety of Siponimod in Patient…Phase 3 · Completed
Links found where a registry record names another trial's registry number.
History
Started
Dec 2014
Main results due
Jul 2017
Finished
Jul 2017
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