Multiple SclerosisNCT04855617
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
An observational study of Multiple Sclerosis, run by NYU Langone Health at 2 sites in United States.
Trial summary
This study is designed to determine whether symptom burden differs by time to infusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Oct 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving ocrelizumab, or potentially starting ocrelizumab will be screened for study inclusion/exclusion criteria.
Who may be able to join
- Age 18-80
- Diagnosis of multiple sclerosis (revised 2017 criteria)
- EDSS 0-7
- Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for >12 months as part of their clinical care
- Individual must be able to provide consent, read/write/comprehend English Language
Who cannot join
- Clinical relapse within 3 months of first on-study infusion
- Cognitive impairment limiting the ability to consent or fill out the electronic survey
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
- Active substance abuse disorder
- Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection)
Show all 9Show fewer
- Chemotherapy use within 6 months of first study infusion
- Prior treatment with alemtuzumab within 12 months of first study infusion
- Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC)
New York, New York, 10016
Elliot Lewis Center for Multiple Sclerosis Care
Wellesley, Massachusetts, 02481
About this study
This study is designed to determine whether symptom burden differs by time to infusion.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Also called OCREVUS
Administer Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions.
- Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.
- Subsequent doses: single 600 mg intravenous infusion every 6 months.
- Observe the patient for at least one hour after the completion of the infusion
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Multiple Sclerosis care | Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores
The NeuroQoL short form will be used for this study, which consists of 5 statements on how much difficulty one currently has during certain activities. Each statement is answered on a scale of 1 (cannot do) to 5 (none); the total range of score is 1-25. The higher the score, the less difficulty one has.
Measured: Week 4, Week 22
Secondary outcomes (2)
Change in SymptoMScreen (SyMS) Scores
SyMS consists of 12 questions. Participants are asked to choose a response that best describes how each MS symptom has affected everyday life activities. Each questions is answered on a scale of 0 (not affected at all) to 6 (total limitation/I'm unable to do most daily activities); the total range of score is 0-72. The higher the score, the higher the limitation from MS symptoms.
Measured: Week 4, Week 22
Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores
There are 2 questions that are quantifiable - they pertain to how much MS has affected one's productivity while working or ability to do regular daily activities. The questions are answered on a scale of 0 (no effect) to 10 (complete prevention); the total range of score is 0-20. The higher the score, the higher the level of prevention.
Measured: Week 4, Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start26 Oct 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ilya Kister, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855617
- Sponsor's protocol ID
- 20-00041
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04855617
- Acronym / sponsor ID
- 20-00041
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine whether symptom burden differs by time to infusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Multiple Sclerosis care | – | Drug: OcrelizumabPatients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving ocrelizumab, or potentially starting ocrelizumab will be screened for study inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- Age 18-80
- Diagnosis of multiple sclerosis (revised 2017 criteria)
- EDSS 0-7
- Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for >12 months as part of their clinical care
- Individual must be able to provide consent, read/write/comprehend English Language
Key exclusion criteria (9 listed)
- Clinical relapse within 3 months of first on-study infusion
- Cognitive impairment limiting the ability to consent or fill out the electronic survey
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
- Active substance abuse disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabAlso: OCREVUSAdminister Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions. * Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion. * Subsequent doses: single 600 mg intravenous infusion every 6 months. * Observe the patient for at least one hour after the completion of the infusion | Drug | Patients Receiving Multiple Sclerosis care |
Primary outcome
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores
Time frame: Week 4, Week 22
The NeuroQoL short form will be used for this study, which consists of 5 statements on how much difficulty one currently has during certain activities. Each statement is answered on a scale of 1 (cannot do) to 5 (none); the total range of score is 1-25. The higher the score, the less difficulty one has.
2 secondary outcomes
Change in SymptoMScreen (SyMS) Scores
Time frame: Week 4, Week 22
Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores
Time frame: Week 4, Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Kister, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores (time frame: Week 4, Week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.