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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Ankylosing Spondylitis (AS); Axial Spondyloarthritis (axSpA)

Treatments: Biological: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03322618

2017-A01705-48 (Other Identifier)

2017-33

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

SpA HLA-B27 +,

Experimental group

Treatment:

Biological: blood samples

SpA HLA-B27-

Experimental group

Treatment:

Biological: blood samples

healthy subject

Active Comparator group

Treatment:

Biological: blood samples