Overview
Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers
Status:
Completed
Completed
Trial end date:
2018-01-01
2018-01-01
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, GrenobleTreatments:
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