Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA

• Status: Completed
• Trial end date: 2020-05-07
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this trial is to search for biomarkers associated with the success of adalimumab treatment in order to generate an algorithm to predict the response to this treatment at 6 months in spondyloarthritis and to define its metrological properties on this cohort.

The algorithm will allow to better target patients who will have an important benefit/risk ratio for adalimumab treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: SINNOVIAL
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Patients with spondyloarthritis validating ASAS or modified New York criteria for which adalimumab treatment is indicated, and performing the pre-biotherapy assessment;

• Between 18 and 70 years old;

• Biotherapy naive;

• Who can be regularly monitored for 6 months;

• Able to take all the treatment;

• Effective contraception for patients of childbearing age (oral contraceptive, intrauterine device, implant, spermicide, surgical sterilization or abstinence) during the study and at least for 5 months after the last injection;

• Able to read and understand the terms of the protocol;

• Having dated and signed the informed consent form of the trial;

• Affiliated to a social security scheme.

Exclusion Criteria:

• Patients having a contraindication to an anti-TNF;

• Surgical operation scheduled during the trial;

• Having difficulty understanding the French language;

• Having impaired upper functions (dementia of Alzheimer type, etc...);

• Psycho-social instability incompatible with regular follow-up (homeless, addictive behavior, history of psychiatric pathology or any other comorbidity which would make a free and informed consent impossible or limit adherence to the protocol);

• Having previously received a biotherapy. There is no other exclusion criteria taking into account prior therapies and the duration of these therapies;

• Described in articles L.1121-5 to L.1121-8 of the Personal Status Code: pregnant, parturient and nursing women; persons in detention by judicial or administrative decision; adults subject to a legal protection order;

• Already participating in interventional research.