Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623773
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-03-15
Brief Title:
Study on Structum in Adult Patients with Osteoarthritis TRUST
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Non-Interventional Study on Structum in Adult Patients with Osteoarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST
Brief Summary:
Chondroitin sulfate CS is a SYSADOA and a natural biomacromolecule belonging to the class of glycosaminoglycans CS is a major component of the extracellular matrix ECM where it constitutes an essential component of proteoglycans
To this date no real-world studies have been conducted to precisely describe the burden associated with OA among patients treated with CSTherefore an observational descriptive prospective national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum in Poland
To this date no real-world studies have been conducted to precisely describe the burden associated with OA among patients treated with CSTherefore an observational descriptive prospective national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum in Poland
Detailed Description:
This is an observational descriptive national multicentric prospective longitudinal study which will be conducted over a 6-month follow-up period for each patient The study will not provide or recommend any specific treatment or procedures
All patients affected by OA in the knee for whom Structum is prescribed in a participating center will be screened in a consecutive manner for eligibility The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients
Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits which will usually occur around 3 and 6 months after the initial study visitThe patient enrolment period is expected to be 6 months with a total study duration of 12 months
All patients affected by OA in the knee for whom Structum is prescribed in a participating center will be screened in a consecutive manner for eligibility The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients
Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits which will usually occur around 3 and 6 months after the initial study visitThe patient enrolment period is expected to be 6 months with a total study duration of 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None