Image

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

The study is a pilot, observational, retrospective, and (italian) multicenter study.

The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres.

Description

The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more data are needed to improve knowledge in this rare disease. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. Infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Eligibility

Inclusion Criteria:

  1. Histologically confirmed diagnosis of R/R MCD HIV and HHV-8 negative patients who underwent siltuximab in a real-life context from July 2016 till April 2022.
  2. Age ≥ 18 yearsatenrollment
  3. Signature of written informed consent (where applicable)

Exclusion Criteria:

  1. R/R MCD patients who underwent siltuximab in a clinical trial context

Study details
    Castleman Disease

NCT06720870

IRCCS Azienda Ospedaliero-Universitaria di Bologna

14 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.