Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-21 @ 4:18 PM
Study NCT ID:
NCT03033095
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers
Status:
COMPLETED
Status Verified Date:
2022-06
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:
PRESA
Brief Summary:
The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease.
This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.
This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.
Detailed Description:
Spondyloarthritis (or spondyloarthropathy) is an inflammatory rheumatic disease that causes arthritis. It differs from other types of arthritis because it involves the sites where ligaments and tendons are attached to bones called "entheses."
All patients should get physical therapy and make exercises for joints. Exercises that promote spinal extension and mobility are the most recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in a short or long-term use. However, physicians have to be aware of potential cardiovascular, renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must be followed regularly. Until now, there is no algorithm which can predict the response to TNF-inhibitors, and more especially for etanercept treatment.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to etanercept for a cohort of patients who suffer from spondyloarthritis.
The development of a predictive algorithm for etanercept treatment will be set up from biological data and finalized with the availibility of clinical data (M6) of the patients .
A modelling by logistic regression will be used, incorporing the set of available variables.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an indicated treatment of etanercept.
All patients should get physical therapy and make exercises for joints. Exercises that promote spinal extension and mobility are the most recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in a short or long-term use. However, physicians have to be aware of potential cardiovascular, renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must be followed regularly. Until now, there is no algorithm which can predict the response to TNF-inhibitors, and more especially for etanercept treatment.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to etanercept for a cohort of patients who suffer from spondyloarthritis.
The development of a predictive algorithm for etanercept treatment will be set up from biological data and finalized with the availibility of clinical data (M6) of the patients .
A modelling by logistic regression will be used, incorporing the set of available variables.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an indicated treatment of etanercept.
Study Oversight
Has Oversight DMC:
False
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?: