Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Secondary Progressive Multiple Sclerosis

Treatments: Procedure: Blood Draw; Procedure: CSF collection by lumbar puncture (Optional)

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT02330965

DAIT AMS04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

36 participants in 2 patient groups

Subjects Assigned to BAF312

Description:

Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive BAF312 (siponimod). Refer to ClinicalTrials.gov record NCT01665144 for more information.

Treatment:

Procedure: CSF collection by lumbar puncture (Optional)

Procedure: Blood Draw

Subjects Assigned to Placebo (Controls)

Description:

Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive placebo. Refer to ClinicalTrials.gov record NCT01665144 for more information.

Treatment:

Procedure: CSF collection by lumbar puncture (Optional)

Procedure: Blood Draw