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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: 31 October 2022
Main ID:  NCT05414487
Date of registration: 06/06/2022
Prospective Registration: Yes
Primary sponsor: Tianjin Medical University General Hospital
Public title: Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases OMNISCIENCE
Scientific title: Exploring the Effects of B Cell Depletion With Ofatumumab on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases - a Prospective Observational Study
Date of first enrolment: October 15, 2022
Target sample size: 34
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT05414487
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
China
Contacts
Name:     Chao Zhang, M.D., Ph.D.
Address: 
Telephone: +8602260814587
Email: chaozhang@tmu.edu.cn
Affiliation: 
Name:     Chao Zhang, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation: 
Name:     Chao Zhang, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Department of Neurology, Tianjin Medical University General Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent

2. RRMS subtype according to 2017 McDonald diagnostic criteria

3. Diagnosis of NMOSD according to the 2015 International Panel diagnostic criteria for
NMOSD with AQP4-IgG

4. Newly diagnosed with MS/NMOSD and initiating ofatumumab treatment within the next 3
months

Exclusion Criteria:

1. Hypersensitivity to trial medications

2. History of life-threatening reaction to Ofatumumab

3. Acute or uncontrolled chronic medical condition

4. Have been treated with medications as specified or within timeframes specified (e.g.
corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide,
claridbine, etc.)

5. Impaired hearing

6. Claustrophobia

7. 300 lbs of greater (weight limit of MRI table)

8. Pregnancy or breastfeeding

9. Sensitivity to imaging agents

10. Contraindications to MRI

11. Use of benzodiazepines, topiramate, doxycycline, mynocicline



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Neuromyelitis Optica Spectrum Disorder
Multiple Sclerosis
Demyelinating Diseases of the Central Nervous System
Intervention(s)
Drug: Ofatumumab
Primary Outcome(s)
Change from baseline in Time to Peak (TTP) of the meningeal lymphatic vessels in superior sagittal sinus (mLVs-SSS) to the end of study. [Time Frame: Baseline, Up To 12months (End of Study)]
Secondary Outcome(s)
Immune cells landscape over time [Time Frame: Baseline, month 3, month 6, month 12]
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study [Time Frame: Baseline, Up To 12months (End of Study)]
Percentage of participants with new lesions by MRI assessments from baseline to the end of study [Time Frame: Baseline, Up To 12months (End of Study)]
Adjudicated On-trial Annualized Relapse Rate (ARR) [Time Frame: Baseline, Up To 12months (End of Study)]
Secondary ID(s)
COMB157GCN02T
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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