Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers (PRESA)

June 13, 2022 updated by: University Hospital, Grenoble

Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with spondylarthritis validating ASAS or New York modified critera, and for who etanercept is indicated.
  • Naïve from biological Drug Modifying Anti Rheumatic Drugs
  • patients between 18 and 70 years old
  • patients who can be monitored at 6 months ;
  • patients who can observe the entire treatment ;
  • patiens with age to procreate under effective contraception ((abstinence, oral contraceptives , intrauterine devices , implants, spermicide or surgical sterilization ) during the study and for 6 months, 3 weeks after the last injection.
  • patients able to understand and accept the terms of the study
  • patients having signed the informed consent.
  • patients insured under social security

Exclusion Criteria:

  • patients of age protected ;
  • patients with difficulties for understanding french language ;
  • patients with high function disorders incompatible with an education program (dementia Alzheimer's type , etc ...) ;
  • patients with psycho- social instability incompatible with regular monitoring (homeless , addictive behavior ,etc.) ;
  • patients in a socio- professional situation incompatible with optimal attendance to the program - - Pregnant or nursing patients
  • patients who received previously a biotherapy treatment . There is no other exclusion criteria taking into account previous treatments and the duration of them.
  • contraindication to the use of anti- TNF treatment
  • Surgery scheduled during the study.
  • Persons mentioned in Articles L.1121-5 to L.1121-8 of the Public Health Code

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: etanercept

The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.

Modality of administration :

Etanercept : 50 mg / week subcutaneously, every 7 days The clinical response will be evaluated after 6 months of etanercept treatment, at the M6 visit.
Drug: Etanercept ® 50 mg
The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.
Other Names:
  • ENBREL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score )
Time Frame: 6 months after inclusion
An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of BASDAI response
Time Frame: 6 months after inclusion
Sensitivity and specificity of the algorithm for BASDAI response : BASDAI response 50, that means an improvement of BASDAI response of 50% or more
6 months after inclusion
biomarkers analysis for personalized medicine
Time Frame: at the inclusion and 6 months after

8 biomarkers will be analysed :

  • calcium-binding protein complex S100A8/A9,
  • prealbumin,
  • haptoglobin (Hapto),
  • protéine C-réactive (CRP),
  • α1 anti-trypsin
  • apolipoprotéinA1 (ApoA1),
  • platelet factor 4 (PF4),
  • S100A12 protein,
at the inclusion and 6 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Athan BAILLET, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

March 28, 2018

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC16.018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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