Overview

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

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Grenoble
Treatments:
Etanercept
Criteria
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