Overview

This trial is active, not recruiting.

Condition secondary progressive multiple sclerosis
Treatments blood draw, csf collection by lumbar puncture (optional)
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Autoimmunity Centers of Excellence
Start date December 2014
End date December 2018
Trial size 40 participants
Trial identifier NCT02330965, DAIT AMS04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive BAF312 (siponimod). Refer to ClinicalTrials.gov record NCT01665144 for more information.
blood draw Phlebotomy
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) CSF by LP
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.
Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive placebo. Refer to ClinicalTrials.gov record NCT01665144 for more information.
blood draw Phlebotomy
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) CSF by LP
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.

Primary Outcomes

Measure
Change in frequency of MBP-reactive Th17 cells
time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

Secondary Outcomes

Measure
Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells
time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Change in chemokine and cytokines levels
time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Change in Regulatory B Cells
time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Changes of clinical status and lymphocyte subgroups
time frame: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).