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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 September 2022 |
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Main ID: |
NCT03322618 |
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Date of registration:
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17/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
KIR3DL2 |
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Scientific title:
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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 |
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Date of first enrolment:
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December 18, 2017 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03322618 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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jean olivier ARNAUD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique Hopitaux De Marseille |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Axial Spondyloarthritis (axSpA)
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Ankylosing Spondylitis (AS)
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Intervention(s)
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Biological: blood samples
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Primary Outcome(s)
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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)
[Time Frame: 12 MONTHS]
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Secondary Outcome(s)
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Dosage of cytokines
[Time Frame: 12 MONTHS]
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Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
[Time Frame: 12 MONTHS]
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Secondary ID(s)
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2017-33
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2017-A01705-48
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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