Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.
NCT ID: NCT05576779
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2101 participants
OBSERVATIONAL
2020-12-03
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Ofatumumab in Real-world Practice
NCT06760624
Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
NCT06737419
A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients
NCT06897657
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
NCT06167642
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
NCT06869785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.
The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ofatumumab
all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Ofatunumab
All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Non-ofatumumab
patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ofatunumab
All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
-. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
* Patients with linkage to the Dx database.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
East Hanover, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for COMB157GUS11 from the Novartis Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COMB157GUS11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.