Immune Disease Clinical Trial
— ANTI-CD303Official title:
Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With Autoimmune Diseases
Verified date | August 2020 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The pathogenic role of type I interferons (IFNs) in the development of different autoimmune
diseases has been extensively described in the literature. Since plasmacytoid dendritic cells
(pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in
autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed
by the pDCs.
The hypothesis leading to the realization of this study is to observe, in vitro, an
inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients
with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB
Group, which could reduce the inflammatory response and improve patients with autoimmune
disease
Status | Completed |
Enrollment | 138 |
Est. completion date | May 25, 2019 |
Est. primary completion date | May 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures - Patient followed in the department of internal medicine of CHU Lille - Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura - Being socially insured Exclusion Criteria: - Overlapping syndrome with another autoimmune disease - Age =18 years - Pregnant or nursing women - People in emergencies - Person incapable of consent - Persons deprived of liberty - Persons without social security cover |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Claude Huriez, CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Laboratoire français de Fractionnement et de Biotechnologies |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | in vitro determination of the level of type I interferons by immunoenzymatic ELISA method. | Baseline | ||
Secondary | in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA) | Baseline | ||
Secondary | in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03994302 -
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