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NCT06644638 · ClinicalTrials.gov registry record
Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis
A clinical trial, sponsored by Novartis.
- Completed
- Registry status
- 3,632
- Enrollment target
NCT06644638: Completed study, sponsored by Novartis.
NCT06644638 is a clinical trial that has completed, run by Novartis. The registered enrollment target is 3,632 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06644638 has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- 3,632 participants
- Enrollment target
Study 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 (i.e., 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.'
Primary Outcome
Persistence was defined as no evidence of discontinuation of the therapy over the follow-up period. Self-injectable DMTs included daclizumab, glatiramer acetate, interferon beta-1a, peginterferon beta-1a, and interferon beta-1b.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,632 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2023-10-30 |
What the finished NCT06644638 record still lists
NCT06644638 is an observational study that tracks outcomes without assigning an intervention. Its 3,632 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT06644638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06644638 about?
NCT06644638 is a clinical study titled "Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis". 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 (i.e., paid by the health plan) medical and pharmacy claims and is representative of the commercially insured United St...
What is the current status of trial NCT06644638?
This trial is currently completed. The enrollment target is 3,632 participants. The study started on 2023-02-15. Estimated completion is 2023-10-30.
Who is sponsoring clinical trial NCT06644638?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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