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Ocrelizumab Effects on the Metabolome in MS

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ClinicalTrials.gov Identifier: NCT03873389
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

In this observational study, the investigators aim to recruit 50 patients over an 10-12 month period. The investigators will recruit patients with relapsing-remitting MS (based on 2017 McDonald Criteria) beginning treatment with ocrelizumab and fulfilling study inclusion and exclusion criteria. Participants recruited in this study will be participants in the Johns Hopkins MS Precision Medicine Center of Excellence bio-banking protocol which requires collection of serum and plasma at 6-monthly intervals and hence will have blood collection performed prior to Ocrevus start and then at 6, 12, 18 and 24 months following ocrelizumab initiation as part of the bio-banking protocol. All recruited participants will provide written informed consent.

The investigators will collect demographic and clinical characteristics at baseline and update these at follow-up visits. These will include disease duration, co-morbidities, relapses, treatment status and history. The investigators will also collect physiological variables - height and weight at each visit.

All recruited patients will return for follow up visits at 6,12, 18 and 24 months post-ocrelizumab initiation. At each visit patients will undergo the following evaluations - EDSS, MSFC, SDMT, fatigue scale (MFIS), quality of life measure (MS-QOL), depression scale (Beck depression inventory, 2nd version) and Block Food Frequency Questionnaire.

The investigators will then utilize plasma collected at the various time points to perform global metabolomics analysis. This will yield measures of various metabolites in the circulation, including amino acids and metabolites of the amino acids. The investigators will utilize this data to determine the change in the circulating metabolome produced by treatment with ocrelizumab.

Following this the investigators will assess changes in the various clinical measures collected - disability (EDSS, MSFC), cognition (SDMT), mood (BDI-II), fatigue (MFIS) and quality of life (MS-QOL) with Ocrelizumab treatment and correlate these with the changes noted in the metabolome. This approach will allow us to determine whether the metabolic changes are associated with/ could underlie the changes noted in clinical measures.


Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Ocrelizumab

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS)
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Group/Cohort Intervention/treatment
Ocrelizumab
All participants enrolled in the study. All participants will be receiving the treatment of interest (Ocrelizumab)
Drug: Ocrelizumab
Patients who are beginning this medication based on patient's treating physician's recommendation will be enrolled in the study.
Other Name: Ocrevus




Primary Outcome Measures :
  1. Change in Global metabolomic profile [ Time Frame: Baseline to 24 months ]
    Change in relative abundance of various metabolites, including amino acids and metabolites of the amino acids, in plasma measured using mass spectrometry


Secondary Outcome Measures :
  1. Change in Expanded Disability Status Scale [ Time Frame: Baseline to 24 months ]
    Change in level of disability as measured by a structured neurological examination resulting in the participants being rated on a scale from 1-10. Higher scores reflect greater physical disability.

  2. Change in Multiple Sclerosis Functional Composite score [ Time Frame: Baseline to 24 months ]
    Change in the multiple sclerosis functional composite which consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality.

  3. Change in Modified Fatigue Impact Scale score [ Time Frame: Baseline to 24 months ]
    Change in scores on the modified fatigue impact scale which has 21 questions regarding the impact of fatigue on daily activities and scores range from 0-84. Higher scores reflect greater impact of fatigue on functioning.

  4. Change in Multiple Sclerosis Quality of Life score [ Time Frame: Baseline to 24 months. ]
    Change in physical and mental health scores as assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. Two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. Higher scores suggest a better quality of life.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be patients diagnosed with relapsing remitting multiple sclerosis between 18 and 75 years of age who are being started on ocrelizumab by the treating neurologist, are willing to return for visits every six months and do not have any other neurological disorder or significant metabolic comorbidity.
Criteria

Inclusion Criteria:

  • Between 18-75 years of age
  • Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on 2017 McDonald Criteria
  • Initiating treatment with Ocrelizumab based on decision of the treating physician
  • Able to return for visits every 6 months to Johns Hopkins MS Center

Exclusion Criteria:

  • Presence of additional neuroinflammatory or neurodegenerative disorder
  • Steroids within the past 30 days
  • Other significant metabolic comorbidity - eg: uncontrolled hypothyroidism or diabetes
  • Likely to switch therapy in the following year
  • Previous treatment with rituximab or other chemotherapy agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873389


Contacts
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Contact: Jesse Ritter, MHS 410-502-2488 jritte15@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jesse Ritter, MHS    410-502-2488    jritte15@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Genentech, Inc.
Investigators
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Principal Investigator: Pavan Bhargava, MBBS, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03873389     History of Changes
Other Study ID Numbers: IRB00205181
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs