CompletedNot Applicable

Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples

France24 participantsStarted 2017-12-18

Plain-language summary

the main objectives are 1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients. The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.

Who can participate

Age range

18 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: * Informed consent of the patient signed before any procedure planned to the protocol * SPA axial according to the criteria of the ASAS (international Assessment of SpondyloArthritis Society) * Known Status HLA B27 * Disease activates with a score of BASDAI = 4/10. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the SPA. * Naive Patients of thorough treatment * Patients of 18 and more years old Exclusion Criteria: * Minors * Pregnant or breast-feeding Women * Adults under guardianship * People staying in a sanitary or social establishment * People in emergency situation * Not profitable People of a national insurance scheme * Private persons of freedom * Treatment by corticoids during the last 30 days before the inclusion * Treatment by anti-TNF or quite different biomedicine * Treatment by sulfasalazine * Reached concomitant by another active chronic inflammatory disease * Infection chronicles by VHB, VHC or HIV * Patients included in another study of clinical trial

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

Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)

Timeframe: 12 MONTHS

Trial details

NCT IDNCT03322618

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-17

View on ClinicalTrials.gov More Axial Spondyloarthritis (axSpA) trials