Secondary Progressive Multiple Sclerosis
Conditions
Keywords
autoimmunity, clinical research, mechanistic studies, blood draw, cerebrospinal fluid (CSF) by lumbar puncture (optional)
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.
Interventions
PROCEDUREBlood 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.
PROCEDURECSF 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.
Sponsors
Autoimmunity Centers of Excellence
Novartis Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Compare BAF312 and Placebo (Control) Groups |
| Change in chemokine and cytokines levels | 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 | 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 | From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). | Compare BAF312 and Placebo (Control) Groups |
Countries
United States
Outcome results
None listed