Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
KIR3DL2
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedStudy Start
First participant enrolled
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2019
CompletedSeptember 1, 2022
August 1, 2022
1.7 years
October 17, 2017
August 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
by flow cytometry.
12 MONTHS
Secondary Outcomes (2)
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
12 MONTHS
Dosage of cytokines
12 MONTHS
Study Arms (3)
SpA HLA-B27 +,
EXPERIMENTALSpA HLA-B27-
EXPERIMENTALhealthy subject
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
jean olivier ARNAUD
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 26, 2017
Study Start
December 18, 2017
Primary Completion
September 17, 2019
Study Completion
September 17, 2019
Last Updated
September 1, 2022
Record last verified: 2022-08