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

Not Applicable

Completed

• Conditions: Axial Spondyloarthritis (axSpA); Ankylosing Spondylitis (AS)
• Interventions: Biological: blood samples

• Registration Number: NCT03322618
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-26
• Study Start: 2017-12-18
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpA HLA-B27 +,	blood samples	-
SpA HLA-B27-	blood samples	-
healthy subject	blood samples	-

Primary Outcome Measures

Name	Time	Method
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)	12 MONTHS	by flow cytometry.

Secondary Outcome Measures

Name	Time	Method
Dosage of cytokines	12 MONTHS
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers	12 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France