Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644638
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a retrospective cohort study utilizing the IQVIA PharMetrics Plus claims database from 01 August 2019 through 31 May 2022
The database is comprised of fully adjudicated ie paid by the health plan medical and pharmacy claims and is representative of the commercially insured United States population Adults treated with ofatumumab OMB oral disease-modifying therapies DMTs dimethyl fumarate diroximel fumarate monomethyl fumarate fingolimod siponimod ozanimod ponesimod teriflunomide cladribine or platform self-injectable DMTs glatiramer acetate interferon beta-1a peginterferon beta-1a interferon beta-1b between 01 August 2020 through 30 November 2021 were identified The date of the first incident DMT OMB oral DMT or injectable DMT during the identification window served as the index date The baseline period was the 12 months before the index date and the follow-up period was at least 6 months after the index date Patients treated with OMB were selected first to maximize sample size and these patients were allowed to have an oral or injectable DMT in the baseline period Patients without OMB use during the identification period were categorized into the oral DMT or platform self-injectable DMT cohort based on the first-observed incident DMT during the identification period For the purpose of this study platform self-injectable DMTs were referred to as self-injectable DMTs
The database is comprised of fully adjudicated ie paid by the health plan medical and pharmacy claims and is representative of the commercially insured United States population Adults treated with ofatumumab OMB oral disease-modifying therapies DMTs dimethyl fumarate diroximel fumarate monomethyl fumarate fingolimod siponimod ozanimod ponesimod teriflunomide cladribine or platform self-injectable DMTs glatiramer acetate interferon beta-1a peginterferon beta-1a interferon beta-1b between 01 August 2020 through 30 November 2021 were identified The date of the first incident DMT OMB oral DMT or injectable DMT during the identification window served as the index date The baseline period was the 12 months before the index date and the follow-up period was at least 6 months after the index date Patients treated with OMB were selected first to maximize sample size and these patients were allowed to have an oral or injectable DMT in the baseline period Patients without OMB use during the identification period were categorized into the oral DMT or platform self-injectable DMT cohort based on the first-observed incident DMT during the identification period For the purpose of this study platform self-injectable DMTs were referred to as self-injectable DMTs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: