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NCT06760624 · ClinicalTrials.gov registry record
Effectiveness of Ofatumumab in Real-world Practice
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 779
- Enrollment target
NCT06760624: Completed study, sponsored by Novartis Pharmaceuticals.
NCT06760624 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 779 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06760624 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 779 participants
- Enrollment target
Study Summary
This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration \[FDA\] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy \[DMT\]), discontinuation of enrollment, or end of study period on 31 December 2023.
Primary Outcome
The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 779 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2024-01-15 |
What the finished NCT06760624 record still lists
NCT06760624 is an observational study that tracks outcomes without assigning an intervention. The registered 779 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06760624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06760624 about?
NCT06760624 is a clinical study titled "Effectiveness of Ofatumumab in Real-world Practice". This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administra...
What is the current status of trial NCT06760624?
This trial is currently completed. The enrollment target is 779 participants. The study started on 2023-10-24. Estimated completion is 2024-01-15.
Who is sponsoring clinical trial NCT06760624?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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