A Systems Approach to Understanding Disease Processes in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Providence Health & Services
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Proportion of relapse free patients
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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:
Exclusion Criteria
- •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 .
Arms & Interventions
Patients with relapsing MS
Patients with relapsing remitting MS who are intending to receive ocrelizumab.
Intervention: All patients in the study will be treated with ocrelizumab (Drug)
Outcomes
Primary Outcomes
Proportion of relapse free patients
Time Frame: 6, 12, and 30 months
Number of participants free of MS relapse at 6, 12, and 30 months divided by total number of participants.
Secondary Outcomes
- Correlates of T2 lesions on-study MRI activity(12, 24, and 30 months)
- Low Contrast Visual Acuity (LCVA)(6, 12, and 30 months)
- Expanded Disability Status Scale (EDSS)(12 and 30 months)
- Timed 25-Foot Walk (T25FW)(6, 12, and 30 months)
- 9-Hole Peg Test (9HPT)(6, 12, and 30 months)
- Annualized relapse rate (ARR)(12 and 30 months)
- Beck Depression Inventory (BDI-2)(6, 12, and 30 months)
- Correlates of gadolinium enhancing lesions on-study MRI activity(12, 24, and 30 months)
- Modified Fatigue Impact Scale (MFIS)(6, 12, and 30 months)
- Symbol digit modality test (SDMT)(6, 12, and 30 months)