CompletedNot Applicable

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

France50 participantsStarted 2018-06-14

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 detenti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of disease activity: AS-DAS (Ankylosing Spondylitis - Disease Activity Score)

Timeframe: 6 months after baseline

Trial details

NCT IDNCT03561649

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-14

View on ClinicalTrials.gov More Spondylitis, Ankylosing trials