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

Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06460324
• Other study ID #: COMB157GUS27
• Status: Completed
• Start date: May 20, 2022
• Est. completion date: July 3, 2023

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Initial COVID-19 vaccination.

2. Booster vaccination.

• Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:

1. Full COVID-19 vaccination course.

2. 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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status	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).	From 2 weeks up to 6 months post-vaccine
Primary	Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)	DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.	From 2 weeks up to 6 months post-vaccine
Secondary	Mean Age at Index Date by Vaccination Status	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.	Index date
Secondary	Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)	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.	Index date
Secondary	Gender at Index Date by Vaccination Status	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.	Index date
Secondary	Gender at Index Date by Prior DMT	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.	Index date
Secondary	Race at Index Date by Vaccination Status	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.	Index date
Secondary	Race at Index Date by Prior DMT	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.	Index date
Secondary	Number of Patients per United States Region at Index Date by Vaccination Status	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.	Index date
Secondary	Number of Patients per United States Region at Index Date by Prior DMT	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.	Index date
Secondary	Time since MS Diagnosis at Index Date by Vaccination Status	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.	Index date
Secondary	Time since MS Diagnosis at Index Date by Prior DMT	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.	Index date
Secondary	Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status	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.	Index date
Secondary	Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT	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.	Index date
Secondary	Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status	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.	Index date
Secondary	Number of Patients with Secondary Progressive MS at Index Date by Prior DMT	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.	Index date
Secondary	Number of Patients with Primary Progressive MS at Index Date by Vaccination Status	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.	Index date
Secondary	Number of Patients with Primary Progressive MS at Index Date by Prior DMT	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.	Index date
Secondary	Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status	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.	Within 12 months preceding index date
Secondary	Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT	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.	Within 12 months preceding index date
Secondary	Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status	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.	Within 12 months preceding index date
Secondary	Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT	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.	Within 12 months preceding index date
Secondary	Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status	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).	Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)
Secondary	Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT	DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.	Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination)