Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728008
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2023-01-30
Brief Title:
Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
Ulcerative colitis UC is a chronic remitting and relapsing inflammatory bowel disease The pathogenesis is multifactorial involving genetic predisposition epithelial barrier defects dysregulated immune responses and environmental factors It is diagnosed through colonoscopy and histological evidence of mucosal inflammation involving predominantly the rectum and potentially extending continuously up to the proximal segments of the colon The patients affected present with severe abdominal pain bloody diarrhea together with extraintestinal manifestations such as peripheral arthritis pyoderma gangrenosum erythema nodosum ankylosing spondylitis and many others The last 20 years have been profitable from the therapeutical point of view thanks to the advent of biological drugs which are derived from a living organism or its products including antibodies interleukins and other molecules capable to target specific cellular pathways and to modulate different mechanisms such as blocking the actions of cytokines or white cells movement in the gut More recently new promising alternatives seems to be the so-called small molecule drugs which are chemically derived low molecular weight compounds capable to enter the cell to regulate its functions and more generally biological processes like inflammation In the last years the therapeutic offer for ulcerative colitis patients has been enriched with the advent of biologics with different mechanism of action and very recently with the availability of the small molecules Currently the available therapeutic options for ulcerative colitis include topic and systemic mesalazine topic and systemic glucocorticoids immunosuppressants thiopurines biological drugs anti-tumor necrosis factor α TNFα inhibitor of α4β7 integrin anti-IL12-23 and small molecules JAK inhibitors However if on the one hand the therapeutical enrichment has clearly improved the disease rate control still there is the need to perform sequencing study to stratify the available options to provide the best and most appropriate patient-oriented management
Detailed Description:
This is an observational retrospective international multicenter study on the comparison of ustekinumab anti-IL12-23 and tofacitinib pan JAK inhibitor used as third-line therapy in UC cases
The aim of this retrospective multicentric observational study is to determine which between ustekinumab anti-IL12-23 and tofacitinib pan JAK inhibitor as third-line therapy in UC cases refractory to both anti-TNFα and vedolizumab inhibitor of α4β7 integrin is the best compound to achieve disease control The primary goal is to compare the hospitalization rate surgery rate drug optimization rate and the drug discontinuation rate as a composite primary objective in patients on either of the two drugs
Subjects received the drugs as per clinical practice starting from their marketing authorization up to February 2022 The data will be collected starting from the time of diagnosis of UC up to last follow-up This study does not require specific procedures as it is intended for the collection and analysis of data from treatments already carried out
The aim of this retrospective multicentric observational study is to determine which between ustekinumab anti-IL12-23 and tofacitinib pan JAK inhibitor as third-line therapy in UC cases refractory to both anti-TNFα and vedolizumab inhibitor of α4β7 integrin is the best compound to achieve disease control The primary goal is to compare the hospitalization rate surgery rate drug optimization rate and the drug discontinuation rate as a composite primary objective in patients on either of the two drugs
Subjects received the drugs as per clinical practice starting from their marketing authorization up to February 2022 The data will be collected starting from the time of diagnosis of UC up to last follow-up This study does not require specific procedures as it is intended for the collection and analysis of data from treatments already carried out
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