NCT05950308

Brief Summary

Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 14, 2023

Last Update Submit

July 14, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants

    varied up to 6 months

  • Percentage of participants achieving T-cell response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants

    varied up to 6 months

Study Arms (4)

HC

Healthy control

OFA

Received ofatumumab

OCR

Received ocrelizumab

S1P

Received sphingosine-1-phosphate receptor modulator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

  • All Participants:
  • Aged 18-75 years old MS Patients
  • Diagnosed with MS based on 2017 McDonald criteria

You may not qualify if:

  • All Participants:
  • Participants with a known history of COVID-19 Healthy Adults
  • Immunocompromised or on immunosuppressive therapy MS Patients
  • None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 18, 2023

Study Start

January 5, 2022

Primary Completion

July 14, 2022

Study Completion

July 14, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

US(1)