An observational study in Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder and Demyelinating Diseases of the Central Nervous System, sponsored by Tianjin Medical University General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Tianjin Medical University General Hospital · Observational
This is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (RMS) or Neuromyelitis optica spectrum disorder (NMOSD) after receiving ofatumumab treatment over an observational period of 12 months.
This is an uncontrolled, prospective, observational cohort study in patients with RMS or NMOSD who will receive ofatumumab treatment over an observational period of 12 month. Ofatumumab was administrated 20mg by subcutaneous injection on Days 1, 7 and 14 for initial loading, followed by monthly infusion up to 12 months. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) will be performed to assess meningeal lymphatic flow in participants before and after ofatumumab treatment.The change of immune cell landscape in RMS or NMOSD patients after receiving ofatumumab treatment will be monitored by mass cytometry (CyTOF). Assessments also include clinical assessments( clinical relapse rate and EDSS score) and MRI assessments (T2 lesion load, T1 gadolinium enhancing lesion number).
3,525 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 34 is below the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Tianjin Medical University General Hospital is the lead sponsor of 74 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
17 RMS patients and 17 NMOSD patients prescribed with Ofatumumab will be enrolled after informed consent.
Drug: Ofatumumab
There is no treatment allocation. Patients with MS or NMOSD administered Ofatumumab by prescription will be enrolled. Participants will receive 20mg ofatumumab (20 mg/0.4 ml) by subcutaneous injection. Ofatumumab is administrated at baseline, Day 7, Day 14 and monthly thereafter until the end of the study.
Change from baseline in Time to Peak (TTP) of the meningeal lymphatic vessels in superior sagittal sinus (mLVs-SSS) to the end of study.
The image of mLVs-SSS in participants will be detected by Dynamic contrast-enhanced MRI (DCE-MRI) before and after ofatumumab treatment.MRI images would be analyzed by three radiologists independently, and each of them is blinded to the patients' information. The obtained DCE-MRI data are interpreted semi-quantitatively to generate TTP.
Time frame: Baseline, Up To 12months (End of Study)
Immune cells landscape over time
The dynamics of immune cells in participants will be detected by mass cytometry (CyTOF) before and after ofatumumab treatment.
Time frame: Baseline, month 3, month 6, month 12
Adjudicated On-trial Annualized Relapse Rate (ARR)
The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of patient years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Time frame: Baseline, Up To 12months (End of Study)
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study
Disease-related disability was measured by the EDSS before and after ofatumumab treatment. The EDSS was an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments.
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
Magnetic Resonance Imaging (MRI) will be used to measure presence of increase in number of gadolinium enhancing lesions and T2 lesion load. Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol.
Time frame: Baseline, Up To 12months (End of Study)
Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University General Hospital