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Completed

NCT Number: NCT06460324

A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
  • Fully vaccinated with any FDA-authorized COVID-19 vaccination.
  • Diagnosed with MS.
  • Receiving ofatumumab at the time of either (or both) of the following:
  • Initial COVID-19 vaccination.
  • Booster vaccination.
  • Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:
  • Full COVID-19 vaccination course.
  • Booster vaccine (among patients receiving ofatumumab at the time of the booster).

Exclusion criteria

  • Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).

Treatment and study plan

Primary outcomes

  1. Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status

    Time frame: From 2 weeks up to 6 months post-vaccine

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

  2. Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)

    Time frame: From 2 weeks up to 6 months post-vaccine

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.

Secondary outcomes

  1. Mean Age at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  2. Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  3. Gender at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  4. Gender at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  5. Race at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  6. Race at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  7. Number of Patients per United States Region at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  8. Number of Patients per United States Region at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  9. Time since MS Diagnosis at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  10. Time since MS Diagnosis at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  11. Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  12. Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  13. Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  14. Number of Patients with Secondary Progressive MS at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  15. Number of Patients with Primary Progressive MS at Index Date by Vaccination Status

    Time frame: Index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  16. Number of Patients with Primary Progressive MS at Index Date by Prior DMT

    Time frame: Index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  17. Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status

    Time frame: Within 12 months preceding index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  18. Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT

    Time frame: Within 12 months preceding index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  19. Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status

    Time frame: Within 12 months preceding index date

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

    Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  20. Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT

    Time frame: Within 12 months preceding index date

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P. Index date was defined as the date of completion of full COVID-19 vaccination or the date of booster vaccination.

  21. Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status

    Time frame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)

    Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of:

    • full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or
    • booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or
    • full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination.

    Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).

  22. Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT

    Time frame: Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)

    DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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