NCT06526000Completed
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
Retrospective EMR Study to Assess Changes in Immunoglobulins in Patients With Relapsing Forms of Multiple Sclerosis Treated With Anti-CD20 Monoclonal Antibodies
Source: ClinicalTrials.gov · Last updated 29 Jul 2024
Brief summary (registry, in English)
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice. The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 326 (actual)
- First submitted
- 23 Jul 2024
- Start date
- 11 Oct 2022
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- Novartis
- Diseases
- Multiple sclerosis
- NCT number
- NCT06526000
What you commit to
- Study type: Observational
- Participants enrolled: 326
- From 11 Oct 2022 to the primary completion date, 28 Feb 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.
Prior treatment
- Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
- Participated in an anti-CD20 drug clinical trial during the study period.
Who the study is looking for
- Patients aged 18 years or older at index.
- Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
- Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
- Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.
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 Pharmaceuticals 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.