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A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

NCT05081700 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2024-10-02

No results posted yet for this study

Summary

This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease activity. Identification of such biomarkers could have an immediate clinical utility in identification of MS patients prone to more aggressive disease earlier in their disease course, thus affording the opportunity to better individualize therapy.

In addition, insights from better understanding of the complex interplay of various systems biology factors should improve our understanding of MS in general. The study will recruit 14 patients with relapsing MS who are initiating treatment with ocrelizumab, and follow them for 30 months.

Conditions

Interventions

DRUG

All patients in the study will be treated with ocrelizumab

300 mg of OCR IV infusion will be given on Day 0 followed by a second dose of 300 mg OCR 14 days later ± 2 days, and then 600 mg of OCR as a single infusion will be given every 24 weeks thereafter per standard medical care.

Sponsors & Collaborators

  • Institute for Systems Biology

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Stanley Cohan, MD, PhD · Providence Health & Services

Eligibility

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

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2023-06-27
Completion
2023-11-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05081700 on ClinicalTrials.gov