NCT06760624Completed
Effectiveness of Ofatumumab in Real-world Practice
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 779 (actual)
- First submitted
- 19 Dec 2024
- Start date
- 24 Oct 2023
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT06760624
What you commit to
- Study type: Observational
- Participants enrolled: 779
- From 24 Oct 2023 to the primary completion date, 15 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None.
Who the study is looking for
- Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
- One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
- One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision \[ICD-10\] code G35.xx) any time before the index date and up to 6 months after the index date.
- Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
- Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.