Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-21 @ 3:58 PM
Study NCT ID:
NCT06589895
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's 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:
False
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 Crohn's 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 Crohn's 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 Crohn's 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 Crohn's 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:
False
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?:
False
Is an FDA AA801 Violation?: