Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis

NCT03025269 | Completed

• 1 other identifier: STUDY00001202
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IV, prospective, open-label, single-center, observational, longitudinal, single blinded study. The investigators will examine the effects of Ocrelizumab on cognitive, patient reported outcomes (PROs), quality of life (QoL), multiple sclerosis functional composite (MSFC), working status and magnetic resonance imaging (MRI) outcomes across 12 and 24 months.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (10)

• Absolute cortical atrophy 12

  Absolute change in cortical atrophy between baseline and 12 months

  12 months

• Percent change cortical atrophy 12

  Percent change in cortical atrophy between baseline and 12 months

  12 months

• Absolute cortical atrophy 24

  Absolute change in cortical atrophy between baseline and 24 months

  24 months

• Percent cortical atrophy 24

  Percent change in cortical atrophy between baseline and 24 months

  24 months

• Absolute thalamic atrophy 12

  Absolute change in thalamic atrophy between baseline and 12 months

  12 months

• Percent thalamic atrophy 12

  Percent change in thalamic atrophy between baseline and 12 months

  12 months

• Absolute thalamic atrophy 24

  Absolute change in thalamic atrophy between baseline and 24 months

  24 months

• Percent thalamic atrophy 24

  Percent change in thalamic atrophy between baseline and 24 months

  24 months

• Inflammation foci 12

  Number of leptomeningeal inflammation foci at 12 months

  12 months

• Inflammation foci 24

  Number of leptomeningeal inflammation foci at 24 months

  24 months

Secondary Outcomes (6)

• SDMT score 12

  12 months

• SDMT 24

  24 months

• Memory 12

  12 months

• Memory 24

  24 months

• Verbal learning 12

  12 months

Study Arms (1)

Relapsing MS patients treated with Ocrelizumab

30 patients diagnosed with relapsing forms of multiple sclerosis and newly beginning treatment with Ocrelizumab according to neurologists' orders

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

This is not a drug intervention study, we are doing an observational study with those who have been prescribed Ocrelizumab by their neurologists during clinical routine appointments

Relapsing MS patients treated with Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with relapsing multiple sclerosis who are being treated at the Jacobs Neurological Institute (JNI) in Buffalo, NY

You may qualify if:

• Patient diagnosed with MS according to McDonald criteria
• Age 18-60
• Relapsing disease course
• Expanded Disability Status Scale (EDSS) ≤5.5
• Disease duration \<20 years
• Treatment naive to Ocrelizumab
• Willing and able to comply with the study procedures for the duration of the trial
• Given written informed consent and signed HIPAA Authorization prior to the study
• Normal kidney functioning (creatinine clearance \>59)

You may not qualify if:

• PI guidelines for contraindications of Ocrelizumab (available after FDA approval)
• Significant cognitive impairment (in the opinion of the investigator) or other significant neurological or medical condition that would compromise adherence and completion of the trial, including major depression and developmental disorders affecting cognition
• Have received treatment within 30 days prior to enrollment with steroids or any other concomitant immunomodulatory therapies
• Have received treatment with Natalizumab within 8 weeks prior to enrollment; this is needed to increase confidence that there are no signs of progressive multifocal leukoencephalopathy (PML) on baseline MRI
• Less than 6 months from the use of immunosuppressant agents (e.g., including but not limited to mitoxantrone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil)
• Have received an investigational drug or experimental procedure within the past 30 days
• Women who are pregnant, lactating, or of childbearing age who do not consent to approved contraceptive use during the study
• Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
• Hypersensitivity to trial medications

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Jacobs Institute

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: November 15, 2017
• Primary Completion: January 8, 2022
• Study Completion: January 8, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)