Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT03344094 |
Date of registration:
|
13/10/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
|
Scientific title:
|
Mechanism of Action of Ocrelizumab in Multiple Sclerosis |
Date of first enrolment:
|
October 12, 2017 |
Target sample size:
|
30 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT03344094 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
N/A
|
|
Countries of recruitment
|
United States
| | | | | | | |
Contacts
|
Name:
|
Michael r Ludwig, bs |
Address:
|
|
Telephone:
|
773-702-8604 |
Email:
|
io-ura@lists.uchicago.edu |
Affiliation:
|
|
|
Name:
|
anthony t reder, md |
Address:
|
|
Telephone:
|
7737026204 |
Email:
|
areder@neurology.bsd.uchicago.edu |
Affiliation:
|
|
|
Name:
|
anthony t reder, md |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University of Chicago |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- All patients who are eligible for Ocrelizumab therapy based on FDA criteria
Exclusion Criteria:
- All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
- Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that
would interfere with planned tests.
- Hepatitis B and HIV infections.
- Pregnant or lactating women.
- Hypersensitivity to trial medications.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Immune System Diseases
|
Multiple Sclerosis
|
Intervention(s)
|
Drug: ocrelizumab
|
Primary Outcome(s)
|
Immune subsets, measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy
[Time Frame: 1 year]
|
Secondary ID(s)
|
IRB10681A
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|