Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589895
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Correlation Between RISANKIZUMABs Trough Levels Clinical and Biological Remission in Moderate to Severe Crohns Disease a Retrospective Multicentric Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlation Between RISANKIZUMABs Trough Levels Clinical and Biological Remission in Moderate to Severe Crohns Disease a Retrospective Multicentric Study
Status:
COMPLETED
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:
RISE-CD
Brief Summary:
The goal of this observational study is to determine if as with other therapeutics such as anti-TNF trough levels of Risankizumab are correlated with clinical and biological remission in patients with moderate to severe Crohns disease As part of their regular biological surveillance trough levels of Risankizumab were mesured and clinical and biological data were collected to determine if biological and clinical remission criteria were met
Detailed Description:
The treatment of chronic inflammatory bowel disease has undergone a number of therapeutic revolutions in recent years with the emergence of new biotherapies These include RISANKIZUMAB an anti-IL23 p19 whose ADVANCE MOTIVATE and FORTIFY studies have demonstrated its efficacy in the induction and maintenance phases of Crohns disease Reimbursement in France for this indication is expected in the final quarter of 2024
While for first-line molecules such as anti-TNF alpha the relationship between serum levels and clinical remission is accepted and allows to guide the therapeutic strategy for patients it has yet to be demonstrated for new molecules of interest
We enrolled patients with moderate to severe Crohns disease on Risankizumab in four centers Trough levels of Risankizumab were mesured as a part of their regular medical surveillance routine For each consultation biological and clinical data were collected to determine wether patients were in remission according to our primary outcome or not Data were collected up to 18 months since the introduction of Risankizumab
The objectives of this study were also to identify factors of primary or secondary failure of treatment to determine clinical reponse rate to evaluate tolerance and persistence of treatment
While for first-line molecules such as anti-TNF alpha the relationship between serum levels and clinical remission is accepted and allows to guide the therapeutic strategy for patients it has yet to be demonstrated for new molecules of interest
We enrolled patients with moderate to severe Crohns disease on Risankizumab in four centers Trough levels of Risankizumab were mesured as a part of their regular medical surveillance routine For each consultation biological and clinical data were collected to determine wether patients were in remission according to our primary outcome or not Data were collected up to 18 months since the introduction of Risankizumab
The objectives of this study were also to identify factors of primary or secondary failure of treatment to determine clinical reponse rate to evaluate tolerance and persistence of treatment
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