NCT05081700

A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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.

Detailed description

The main purpose of the study is to improve the understanding of MS and to look at the genetic factors that may influence how MS progresses. This will involve collecting blood and stool samples, patient questionnaires, and MS-related assessments. About 67 mL (13 tsp) of blood will be collected at the first visit, and again at 6 months, 12 months, and 30 months after first visit. Participants will receive standard treatment (ocrelizumab) and have standard exams, MRIs, and tests while on the study. Study participation is about 30 months, which includes about 9 study visits. Some study visits may be up to 5 hours long. 14 people will take part in this study.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-11
• Primary completion: 2023-06-27
• Completion: 2023-11-03
• First posted: 2021-10-18
• Last updated: 2024-10-02

Locations

2 sites across 1 country: United States