Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
NCT ID: NCT03322618
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2017-12-18
2019-09-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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SpA HLA-B27 +,
blood samples
7 tubes of 6 ml (42 ml of blood )
SpA HLA-B27-
blood samples
7 tubes of 6 ml (42 ml of blood )
healthy subject
blood samples
7 tubes of 6 ml (42 ml of blood )
Interventions
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blood samples
7 tubes of 6 ml (42 ml of blood )
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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jean olivier ARNAUD
Role: STUDY_DIRECTOR
Assistance Publique Hopitaux De Marseille
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2017-A01705-48
Identifier Type: OTHER
Identifier Source: secondary_id
2017-33
Identifier Type: -
Identifier Source: org_study_id
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