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

NCT02330965 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2020-11-09

No results posted yet for this study

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.

Conditions

  • Secondary Progressive Multiple Sclerosis

Interventions

PROCEDURE

Blood 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.

PROCEDURE

CSF 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 & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Yang Mao-Draayer, MD, PhD · Multiple Sclerosis Center - University of Michigan Health System

  • David Fox, MD · Division of Rheumatology - University of Michigan Health System

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-07-12
Completion
2017-07-12

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330965 on ClinicalTrials.gov