Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247722
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-22
Brief Title:
Real World Use of Tocilizumab Biosimilar studY
Sponsor:
Fresenius Kabi SwissBioSim GmbH
Organization:
Fresenius Kabi SwissBioSim GmbH
Study Overview
Official Title:
A Multinational Prospective Non-interventional Study to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RUBY
Brief Summary:
The goal of this non interventional study is to evaluate the use of Tyenne a tocilizumab biosimilar in a real world setting in Rheumatoid Arthritis RA patients over a period of 12 months
The main questions it aims to answer are
What is the patients persistence on Tyenne patients ability to continue the treatment for the prescribed duration 6 months after treatment start
What is the patients persistence on Tyenne patients ability to continue the treatment for the prescribed duration 12 months after treatment start
The decision of prescribing Tyenne will be done by the physician independently prior to patient enrolment in the study Enrolled patients will be followed for 12 months following Tyenne treatment start or until they permanently discontinue Tyenne
There will be one baseline visit and three follow-up visits at approximately 3 6 and 12 months after Tyenne treatment initiation All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol
The main questions it aims to answer are
What is the patients persistence on Tyenne patients ability to continue the treatment for the prescribed duration 6 months after treatment start
What is the patients persistence on Tyenne patients ability to continue the treatment for the prescribed duration 12 months after treatment start
The decision of prescribing Tyenne will be done by the physician independently prior to patient enrolment in the study Enrolled patients will be followed for 12 months following Tyenne treatment start or until they permanently discontinue Tyenne
There will be one baseline visit and three follow-up visits at approximately 3 6 and 12 months after Tyenne treatment initiation All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None