Clinical trial NCT03322618: Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
Official title: Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis (axSpA)
Ankylosing Spondylitis (AS)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
timeFrame: 12 MONTHS
measure: Dosage of cytokines
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean olivier ARNAUD
role: STUDY_DIRECTOR
References: