A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT05081700
Run by: Providence Health & Services
People needed: 14
Starts: 2020-05-11
Expected to finish: 2023-11-03
Last updated by the study team: 2024-10-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Able to understand the purpose and risk of the study and provide written informed consent.
Male or female patients aged 18 to 60, inclusive at time of consent, who meet FDA approved indications to receive ocrelizumab treatment.
Have a definite diagnosis of relapsing MS (RMS) (Lublin et al. 2014).
Screening EDSS ≤ 5.0.
Have a length of disease duration since disease symptom onset ≤ 15 years.
Documentation of 1 or more on-DMT relapses, or 1 brain MRI revealing new or enlarged T2 lesion(s) over the 2 years prior to the screening visit (this could include DMT naïve patients).
Patient does not have any clinically significant medical conditions based on medical history, physical examination, and laboratory screening, as defined by the investigator, which would interfere with the conduct of the study.
Patient is willing and able to comply with the protocol assessments and visits, in the opinion of the investigator.
For women of childbearing potential: agreement to use an effective birth control method and avoid breastfeeding during the study period, and for those patients who have received ocrelizumab, for at least 6 months after the last dose.
Inclusion criteria for those patients who have completed the core study and are re-consenting and re-enrolling to complete the month 30 visit. Patients must fulfill all of the following criteria to participate in the study:
Able to understand the purpose and risk of the study and provide written informed consent.
Have participated in the core study and continue to receive ocrelizumab.
Have not passed week 120±14 days post initial ocrelizumab dose in the core study.
Diagnosis of relapsing MS at time of consent.
Patient is willing and able to comply with the protocol assessments and visits, in the opinion of the investigator.
For women of childbearing potential: agreement to use an effective birth control method and avoid breastfeeding during the study period and for at least 6 months after the last dose of ocrelizumab.

You may not qualify if…

Diagnosis of progressive MS at screening.
Patient is unable to undergo MRI with gadolinium contrast imaging for any reason.
Known presence of other neurological disorders, including but not limited to, the following:
History of cerebrovascular disorders.
History or known presence of CNS tumor.
History or known presence of potential metabolic causes of myelopathy.
History of peripheral neuropathy.
History or known presence of infectious disease of the CNS.
History of genetically inherited CNS degenerative disorder.
Neuromyelitis optica spectrum disorder, anti-Aquaporin 4 IgG, or Anti-MOG IgG .
History of progressive multifocal leukoencephalopathy (PML).
History or known presence of any other concurrent systemic or nervous system autoimmune disorders, potentially causing progressive neurologic disease.
History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression).
Exclusions related to general health:
Pregnancy or lactation.
Chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
History or currently active primary or secondary immunodeficiency.
Lack of peripheral venous access.
Hypersensitivity to ocrelizumab or to any of its excipients.
Significant or uncontrolled non-neurological systemic disease.
Significant active infections must be treated and resolved before possible inclusion in the study.
Patients in an immunocompromised state.
Patients with history of malignancy, except for adequately treated basal cell skin cancer or in situ cervical cancer.
Exclusions Related to Medications:
Your last COVID-19 vaccine should be given at least 2 weeks before and all vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted to at least the lower limit of normal. COVID-19 vaccines are permitted per investigator discretion during ocrelizumab treatment.

Where it is running

Providence Neurological Specialties West — Portland, Oregon, United States
Swedish Medical Center Multiple Sclerosis Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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