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| Name | Class |
|---|---|
| Autoimmunity Centers of Excellence | OTHER |
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of MBP-reactive Th17 cells | Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot. | From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells | Compare BAF312 and Placebo (Control) Groups | From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). |
| Change in chemokine and cytokines levels |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan Research & Education Institute: Sutter Alta Bates Summit | Berkeley | California | 94705 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31935197 | Result | 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. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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Blood & Cerebrospinal Fluid Samples
|
| CSF collection by lumbar puncture (Optional) | Procedure | 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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Compare BAF312 and Placebo (Control) Groups
| From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). |
| Change in Regulatory B Cells | Compare BAF312 and Placebo (Control) Groups | From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). |
| Changes of clinical status and lymphocyte subgroups | Compare BAF312 and Placebo (Control) Groups | From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months). |
| University of Southern California |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, Davis | Sacramento | California | 95817 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Michigan Health System -Multiple Sclerosis Center | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | United States |
| University of New Mexico: Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| South Shore Neurologic Associates - Multiple Sclerosis Care Center | Patchogue | New York | 11772 | United States |
| Carolinas Medical Center (CMC) | Charlotte | North Carolina | 28207 | United States |
| Cleveland Clinic: Mellen Center for Multiple Sclerosis | Cleveland | Ohio | 44195 | United States |
| Providence Multiple Sclerosis Center | Portland | Oregon | 97225 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Relevant Clinical Trials.gov Record: NCT01665144 | View source |
| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
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