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Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases (OMNISCIENCE)

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ClinicalTrials.gov Identifier: NCT05414487
Recruitment Status : Not yet recruiting
First Posted : June 10, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Chao Zhang, Tianjin Medical University General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Neuromyelitis Optica Spectrum Disorder Demyelinating Diseases of the Central Nervous System Drug: Ofatumumab

Detailed Description:
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).

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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : June 15, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2024


Group/Cohort Intervention/treatment
Ofatumumab
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.




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. Immune cells landscape over time [ Time Frame: Baseline, month 3, month 6, month 12 ]
    The dynamics of immune cells in participants will be detected by mass cytometry (CyTOF) before and after ofatumumab treatment.

  2. Adjudicated On-trial Annualized Relapse Rate (ARR) [ Time Frame: Baseline, Up To 12months (End of Study) ]
    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.

  3. 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) ]
    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.

  4. 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) ]
    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.


Biospecimen Retention:   Samples With DNA
Peripheral Blood of participants


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. 17 patients with relapsing remitting multiple sclerosis(RRMS)received ofatumumab treatment were enrolled.
  2. 17 patients with NMOSD received ofatumumab treatment were enrolled.
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

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): NCT05414487


Contacts
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Contact: Chao Zhang, M.D., Ph.D. +8602260814587 chaozhang@tmu.edu.cn
Contact: Shu Yang, M.D., Ph.D. +8615922023036 yangshu_0413@163.com

Locations
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China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
Contact: Chao Zhang, M.D., Ph.D.         
Contact: Yi Shen, M.D., Ph.D.         
Principal Investigator: Chao Zhang, M.D., Ph.D.         
Sponsors and Collaborators
Tianjin Medical University General Hospital
Investigators
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Principal Investigator: Chao Zhang, M.D., Ph.D. Department of Neurology, Tianjin Medical University General Hospital
Publications:

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Responsible Party: Chao Zhang, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT05414487    
Other Study ID Numbers: COMB157GCN02T
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chao Zhang, Tianjin Medical University General Hospital:
Multiple Sclerosis
Neuromyelitis Optica Spectrum Disorder
Demyelinating Diseases
Ofatumumab
Meningeal Lymphatic Drainage
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuromyelitis Optica
Demyelinating Diseases
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Ofatumumab
Antineoplastic Agents